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TerminatedNCT03044353Updated Oct 16, 2019Results posted

Multiple Treatment Session Study to Assess GSK2398852 Administered Following and Along With GSK2315698

A Phase 2 interventional study of GSK2315698 (CPHPC) and GSK2398852 (anti-SAP mAb) in Amyloidosis, sponsored by GlaxoSmithKline. Terminated at 3 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-10-16.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment

Why this study was terminated
Change in benefit/risk profile
Phase
Phase 2
Study type
Interventional
Enrollment
7
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The study is intended to evaluate whether monthly repeated courses of administration of GSK2315698 followed by GSK2398852 is associated with a reduction in cardiac amyloid load in patients with cardiac amyloidosis, monitored by cardiac magnetic resonance imaging (CMR) and echocardiography (ECHO), and whether this is associated with an improvement in cardiac function. Cohort 1 is transthyretin cardiomyopathy (ATTR-CM) , cohort 2 is patients with immunoglobulin light chain (AL) systemic amyloidosis at greater than 6 months post chemotherapy, cohort 3 newly diagnosed AL systemic amyloidosis undergoing chemotherapy. Primary objectives for the study are assessment of reduction in cardiac amyloid load after repeated administrations of Anti-SAP treatment as evaluated by CMR in all study groups and assessment of safety \& tolerability of repeated administration of Anti-SAP treatment, including compatibility with chemotherapy treatment in patients with AL systemic amyloidosis. This is an open label, non-randomised, three-group, monthly repeat Anti-SAP treatment study in systemic amyloidosis patients with cardiac dysfunction caused by cardiac amyloidosis. Subjects will receive up to 6 courses of Anti-SAP treatment. Maximum total duration for a subject in the study is approximately 18 months.

02

Conditions studied

  • Amyloidosis

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Keywords

  • echocardiography (ECHO)
  • skin biopsy
  • monoclonal anti-serum amyloid p component antibody (anti-SAP mAb)
  • Amyloidosis
  • cardiac magnetic resonance imaging (CMR)
  • biomarkers
  • cardiac functional measures
  • left ventricular mass
03

In context

Amyloidosis

495 studies on the registry are indexed under Amyloidosis; 135 are open to participants now.

This study's enrollment of 7 is below the median of 40 across 307 interventional studies indexed under Amyloidosis.

Browse Amyloidosis studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.

Browse GlaxoSmithKline studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Between 18 and 80 years of age inclusive, at the time of signing the informed consent.
  • Male and female.

Males:

Male subjects with female partners of child bearing potential must comply with the following contraception requirements from the time of first dose of study medication for a cycle of spermatogenesis following five terminal half-lives after the last dose of study medication. Vasectomy with documentation of azoospermia.

Male condom plus partner use of one of the contraceptive options below: Contraceptive subdermal implant, Intrauterine device or intrauterine system, Combined Oral Contraceptive or Injectable progestogen, Contraceptive vaginal ring, Percutaneous contraceptive patches .

This is an all-inclusive list of those methods that meet the following GlaxoSmithKline (GSK) definition of highly effective: having a failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. For non-product methods (e.g., male sterility), the investigator determines what is consistent and correct use. The GSK definition is based on the definition provided by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.

Females

A female subject is eligible to participate if she is not pregnant (as confirmed by a negative Urine human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies:

  • Non-reproductive potential defined as: Pre-menopausal females with one of the following: Documented tubal ligation; Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; Hysterectomy; Documented Bilateral Oophorectomy.

Postmenopausal defined as: 60 years old; Twelve(12) months of spontaneous amenorrhea with an appropriate clinical profile, e.g. age appropriate, > 45 years, in the absence of hormone replacement therapy (HRT) or medical suppression of the menstrual cycle (e.g. leuprolide treatment) in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and oestradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels). Females on HRT and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.

  • Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) (As mentioned in study protocol) from 30 days prior to the first dose of study medication and until 3 months after the last dose of study medication.

The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception

  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
  • Late-Gadolinum enhancement (LGE) on CMR indicative of cardiac amyloidosis
  • LV mass on CMR > 200 grams (g) Inclusion Criteria for Group 1
  • Transthyretin amyloid (ATTR) cardiomyopathy (CM)
  • Subjects with a diagnosis of hereditary ATTR amyloidosis should have a known amyloidogenic transthyretin (TTR) mutation demonstrated by genotyping AND is recognised to be primarily associated with cardiomyopathy AND one of the following: Definite histochemical identification of amyloid by Congo red staining and green birefringence in crossed polarised light in cardiac or other tissue biopsy and identification of TTR as the amyloid fibril protein either by immunohistochemistry or proteomic analysis.

Or Scintigraphy: 99m\^Tc-DPD with Grade 2 cardiac uptake or 99m\^Tc-PYP with either Grade 2 or 3 cardiac uptake.

  • Subjects with a diagnosis of wild type ATTR-CM must be negative by genotyping and have one of the following: Definite histochemical identification of amyloid by Congo red staining and green birefringence in crossed polarised light in cardiac or other tissue biopsy and identification of TTR as the amyloid fibril protein either by immunohistochemistry or proteomic analysis OR Scintigraphy 99m\^Technetium-dicarboxypropane diphosphonate (99m\^Tc-DPD) with Grade 2 cardiac uptake or 99m\^ Technetium-pyrophosphate (99m\^Tc-PYP) with Grade 2 or 3 cardiac uptake.
  • Clinically stable in New York heart association (NYHA) class 2 or 3 for the 3 months preceding screening

Inclusion Criteria for Group 2

  • Subject medically diagnosed with AL amyloidosis that has required chemotherapy or an autologous stem cell transplant based upon:

AL amyloidosis confirmed by biopsy with immunohistochemical staining or proteomic identification of AL amyloid fibril type, in subjects with definite monoclonal gammopathy in whom causative mutations of all known relevant amyloidogenic genes have been excluded

  • Clinically stable in NYHA class 2 or 3 for the 3 months preceding screening
  • >=6 months after completing any line of chemotherapy, or after autologous stem cell transplantation, and having attained either a very good partial response (VGPR) or a complete response (CR), and without the need for haematological maintenance therapies

Inclusion Criteria for Group 3

  • Newly diagnosed AL amyloidosis based upon:

AL amyloidosis confirmed by biopsy with immunohistochemical staining or proteomic identification of AL amyloid fibril type in subjects with definite monoclonal gammopathy in whom causative mutations of all known relevant amyloidogenic genes have been excluded

  • Mayo stage II or IIIa
  • Confirmed free light chain complete response (CR) during the first three cycles of first-line chemotherapy where at least the first cycle has been with cyclophosphamide, bortezomib, dexamethasone (CyBorD).

Exclusion Criteria:

  • Cardiomyopathy primarily caused by non-amyloid diseases (e.g. ischemic heart disease; valvular heart disease)
  • Interval from the Q wave on the ECG to point T using Fredericia's formula (QTcF) > 500 millisecond (msec)
  • Sustained / symptomatic monomorphic ventricular tachycardia (VT), or rapid polymorphic VT, at screening
  • Unstable heart failure defined as emergency hospitalization for worsening, or decompensated heart failure, or syncopal episode within 1 month of screening.

Implantable cardiac defibrillator (ICD) or permanent pacemaker (PPM) at screening

  • N-terminal pro b-type Natriuretic Peptide [(NT)-proBNP] >8500 nanograms (ng)/ Liter (L)
  • Glomerular filtration rate (GFR) at Screening \< 40 milliliter (mL)/minute (min)
  • Any active and persistent dermatological condition
  • Existing diagnosis of any type of dementia
  • History of allogeneic stem cell transplantation, prior solid organ transplant, or anticipated to undergo solid organ transplantation, or left ventricular assist device (LVAD) implantation, during the course of the study.
  • Malignancy within last 5 years, except for basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix that has been successfully treated.
  • Acute coronary syndrome, or any form of coronary revascularization procedure (including coronary artery bypass grafting [CABG]), within 6 months of screening.
  • Stroke within 6 months of screening, or transient ischaemic attack (TIA) within 3 months of screening
  • Symptomatic, clinically significant autonomic neuropathy which the Principal Investigator (PI) feels will preclude administration of study treatment
  • Hypoalbuminaemia (serum albumin \< 30 g/L)
  • Uncontrolled hypertension during screening
  • Alanine transaminase ALT >3x upper limit of normal (ULN) AND bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%)
  • Peripheral oedema at Screening that in the opinion of the Prinicpal Investigator (PI) or designee might prevent adequate absorption of subcutaneously administered CPHPC
  • Urine dipstick positive (>1+) for blood during screening with investigation indicating glomerular haematuria. If other causes are identified, subjects may be enrolled on resolution of the abnormality
  • Presence of any co-morbid or an uncontrolled medical condition (e.g. diabetes mellitus), which in the opinion of the investigator would increase the potential risk to the subject. Investigator should liaise with the Medical Monitor where there is uncertainty as to the eligibility of a patient
  • Positive test for hepatitis B hepatitis C, and / or human immunodeficiency virus (HIV) during screening, or within 3 months prior to first dose of study treatment
  • Unwillingness or inability to follow the procedures outlined in the protocol
  • Use of GSK2315698 (CPHPC), or participation in a separate clinical trial involving CPHPC within 3 months of screening
  • Any prohibited concomitant medication as per protocol within 28 days of Screening
  • Donation of blood or blood products in excess of 500 mL within 84 days of screening
  • Lactating females
  • Poor or unsuitable venous access
  • Treatment with another investigational drug, biological agent, or device within 6 months of screening, or 5 half-lives of the study agent, whichever is longer.
  • History of sensitivity to any of the study medications, or metabolite thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation CARDIAC MAGNETIC RESONANCE (CMR) SCANNING
  • Orthopnoea of sufficient severity to preclude supine scanning as determined at screening
  • Contraindication to magnetic resonance imaging (MRI) contrast agents
  • Inability to fit inside scanner due to body size (girth)

  • Contraindication for MRI scanning (as assessed by local MRI safety questionnaire), which includes but is not limited to:

    • Intracranial aneurysm clips (except Sugita) or other metallic objects
    • Intra- orbital metal fragments that have not been removed
    • Pacemakers or other implanted cardiac rhythm management/monitoring devices and non-MR conditional heart valves
    • Inner ear implants

    • History of claustrophobia

      99m\^TC-PYP OR 99mTC-DPD BONE TRACER RADIOSCINTOGRAPHY

  • Orthopnoea of sufficient severity to preclude supine scanning as determined at Screening
  • Previous allergic reaction to radioisotope bone tracers
  • Previous inclusion in a research protocol involving nuclear medicine, positron emission tomography (PET) or radiological investigations with significant radiation burden (a significant radiation burden being defined as 10 mSv in addition to natural background radiation, in the previous 3 years).

Exclusion Criteria for Group 1

Has any of the following:

  • Fulfilment of diagnostic criteria for AL amyloidosis
  • TTR polyneuropathy and / or intracranial TTR involvement including ophthalmological disease
  • Non-amyloidosis related chronic liver disease (with the exception of Gilbert's syndrome or clinically asymptomatic gallstones)
  • Platelet count \< 125x10\^9 / L

Exclusion criteria for Group 2

  • Chronic liver disease or current active liver or biliary disease not attributable to amyloidosis (with the exception of Gilbert's syndrome or asymptomatic gallstones).

Exclusion criteria for Group 3

  • Chronic liver disease or current active liver or biliary disease not attributable to amyloidosis (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • Platelet count \< 75x10\^9 /L
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    Group 1: Cardiac TTR amyloidosis (ATTR-CM) participants

    Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy \[ATTR-CM\]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR will be included. Participants will receive 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants will receive CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants will be administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb will be 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC will be administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.

    Drug: GSK2315698 (CPHPC) · Biological: GSK2398852 (anti-SAP mAb)

  • Experimental
    Group 2: Post-chemotherapy AL Amyloidosis participants

    Immunoglobin light chain amyloidosis (AL) participants who attain either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) will be included. Participants will receive 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants will receive CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants will be administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb will be 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC will be administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.

    Drug: GSK2315698 (CPHPC) · Biological: GSK2398852 (anti-SAP mAb)

  • Experimental
    Group 3: Newly diagnosed Mayo stage II/IIIa AL participants

    Newly diagnosed Mayo stage II/IIIa AL participants who attain a free light chain CR during the first 3 cycles of first-line chemotherapy where the first cycle was cyclophosphamide, bortezomib, dexamethasone (CyBorD) will be included. Participants will receive 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants will receive CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants will be administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb will be 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC will be administered as SC injection for 11 days from the day of first dose of anti-SAP mAb.

    Drug: GSK2315698 (CPHPC) · Biological: GSK2398852 (anti-SAP mAb)

Interventions

  • DrugGSK2315698 (CPHPC)

    20mg/hour, IV (in the vein) for up to 72hours followed by 60mg three times daily subcutaneous injection for 11 days. Number of cycles: up to 6. Dose level and frequency adjusted according to renal function

  • BiologicalGSK2398852 (anti-SAP mAb)

    Up to 1200mg, IV divided over days 1 and 3. Number of cycles: up to 6. Dose level adjusted based on tolerability.

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Left Ventricular (LV) Mass Over Time up to 8-week Follow-up

    Left ventricular mass was measured by Cardiac Magnetic Resonance (CMR) imaging to assess reduction in cardiac amyloid load after repeated administration of anti-SAP treatment. Each CMR imaging session took approximately 45-60 minutes, with a maximum scan time inside of the scanner of 90 minutes. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value. Safety Population comprised of all participants who received at least one dose of study treatment (any dose of CPHPC \[GSK2315698\] or anti-SAP mAb \[GSK2398852\]).

    Time frame: Baseline (Day -1) and Session 2 Day 24, Session 3 Day 24, Session 4 Day 24, Session 5 Day 24, 8 Weeks Follow-up

  2. Number of Participants With Any On-treatment Adverse Events (AEs)

    AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with any on-treatment AEs are presented.

    Time frame: Up to 56 days after the last dosing session (up to 265 days)

  3. Number of Participants With Any Serious Adverse Events (SAEs)

    AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, events associated with liver injury and impaired liver function, or any other situation according to medical or scientific judgment were categorized as SAE. Number of participants with any SAEs during study are presented.

    Time frame: Up to the end of study (Up to 369 days)

  4. Number of Participants With Abnormal Hematology Values

    Blood samples were collected for assessment of hematology parameters, which included platelet count, hemoglobin, hematocrit, erythrocytes, reticulocyte count, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), neutrophils, lymphocytes, monocytes, eosinophils, leukocytes and basophils. Abnormal laboratory results are categorized as high, low or normal with respect to their normal ranges. Data for worst case post Baseline is presented. Participants having both High and Low values from Normal Ranges at any post-baseline visits for any parameter was counted in both the High and Low categories.

    Time frame: Up to the end of study (Up to 369 days)

  5. Number of Participants With Abnormal Clinical Chemistry Values

    Blood samples were collected for assessment of clinical chemistry parameters, which included aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), urea, creatinine, glucose, chloride, creatinine kinase, potassium, sodium, calcium, total carbon dioxide (CO2), urate, total and direct bilirubin, total protein and albumin. Abnormal laboratory results are categorized as high, low or normal with respect to their normal ranges. Data for worst case post Baseline is presented. Participants having both High and Low values from Normal Ranges at any post-baseline visits for any parameter was counted in both the High and Low categories.

    Time frame: Up to the end of study (Up to 369 days)

  6. Number of Participants With Abnormal Urinalysis Results

    Urine samples were collected to assess potential of hydrogen (pH), specific gravity, albumin excretion rate, creatinine excretion rate and protein excretion rate. Abnormal urinalysis results are categorized as high, low or normal with respect to their normal ranges. Data for worst case post Baseline is presented. Participants having both High and Low values from Normal Ranges at any post-baseline visits for any parameter was counted in both the High and Low categories.

    Time frame: Up to the end of study (Up to 369 days)

  7. Number of Participants With Abnormal Urinalysis Results for Character Parameters

    Urine samples were collected to assess character parameters which included Cellular Casts, Erythrocytes, Glucose, Ketones, Leukocytes and Occult Blood. Number of participants with abnormal urinalysis results are presented. Data for worst case post Baseline is presented.

    Time frame: Up to the end of study (Up to 369 days)

  8. Number of Participants With Body Temperature Shifts From Baseline Relative to Potential Clinical Importance (PCI) Criteria

    Vital signs including body temperature was measured after participants rested in semi-supine position for at least 5 minutes. Number of participants with shifts in body temperature from Baseline to worst case post Baseline relative to PCI criteria have been presented. PCI results were categorized as to high, to low and to normal/no change with reference to PCI criteria. PCI criteria for body temperature was: high: \>37.5 degree Celsius; low: not applicable.

    Time frame: Up to the end of study (Up to 369 days)

  9. Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Shifts From Baseline Relative to PCI Criteria

    Vital signs including SBP and DBP were measured after participants rested in semi-supine position for at least 5 minutes. Number of participants with shifts in SBP and DBP from baseline to worst case post baseline relative to PCI criteria have been presented. PCI results were categorized as to high, to low and to normal/no change with reference to PCI criteria. PCI criteria for SBP was: high: \>180 millimeter of mercury (mmHg); low: \<90 mmHg. PCI criteria for DBP was: high: \>110 mmHg; low: \<30 mmHg.

    Time frame: Up to the end of study (Up to 369 days)

  10. Number of Participants With Pulse Rate Shifts From Baseline Relative to PCI Criteria

    Vital signs including pulse rate were measured after participants rested in semi-supine position for at least 5 minutes. Number of participants with shifts in pulse rate from baseline to worst case post baseline relative to PCI criteria have been presented. PCI results were categorized as to high, to low and to normal/no change with reference to its PCI criteria. PCI criteria for pulse rate was: high: \>140 beats per minute (bpm); low: \<35 bpm.

    Time frame: Up to the end of study (Up to 369 days)

  11. Number of Participants With Abnormal Electrocardiogram (ECG) Findings

    Twelve-lead ECGs were performed during the study using an automated ECG machine. The number of participants with worst case post-Baseline abnormal ECG findings were reported and categorized as abnormal-clinically significant and abnormal-not clinically significant.

    Time frame: Up to the end of study (Up to 369 days)

  12. Number of Participants With Abnormalities During Cardiac Monitoring

    Lead II telemetry and cardiac monitoring devices were used for electrical cardiac monitoring during the study. The number of participants with worst case post-Baseline abnormalities during cardiac monitoring as per investigator's assessment have been reported and categorized as Abnormal-clinically significant and Abnormal-not clinically significant.

    Time frame: Up to the end of study (Up to 369 days)

  13. Number of Participants for Which Unscheduled Echocardiography (ECHO) Was Performed for Safety Reasons

    Echocardiography was performed by a qualified echocardiographer or cardiologist during the study. Number of participants with unscheduled echocardiograms performed for safety reasons have been presented.

    Time frame: Up to the end of study (Up to 369 days)

  14. Number of Participants With Skin Rashes

    Skin rash was an event of special interest. Only Rashes that were associated with study drug were categorised as Rash for Common Terminology Criteria for Adverse Events (CTCAE) and are presented. Number of participants with on-treatment skin rash AEs are presented.

    Time frame: Up to 56 days after the last dosing session (up to 265 days)

  15. Number of Participants With Skin Rashes Classified Using CTCAE

    Skin rash was an event of special interest. All the events of rashes were graded for their severity using CTCAE version 4.0 . Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life threatening, Grade 5: death. Higher the grade, more severe the symptoms. Only Rashes that were associated with study drug were categorised as Rash for CTCAE and are presented here. Number of participants with skin rashes classified by their maximum grade are presented.

    Time frame: Up to 56 days after the last dosing session (up to 265 days)

Secondary outcomes

  1. Number of Participants With Abnormalities in Histopathological Examination of Skin Biopsies

    Skin biopsy samples were collected for histopathological examination only on any rash development (\>= Grade 1) as decided by clinical judgment of the Investigator and/or dermatologist. Number of participants with abnormalities in histopathological examination of skin biopsies are presented.

    Time frame: Up to the end of study (Up to 369 days)

  2. Number of Participants With Abnormalities in Immunohistochemical Examination of Skin Biopsies

    Skin biopsy samples were collected for immunohistochemical examination only on any rash development (\>= Grade 1) as decided by clinical judgment of the Investigator and/or dermatologist. Number of participants with abnormalities in immunohistochemical examination of skin biopsies are presented.

    Time frame: Up to the end of study (Up to 369 days)

  3. Number of Participants With Abnormalities in Histopathological Examination of Blood Biomarkers

    Blood samples were to be collected along with each skin biopsy sample for histopathological examination of blood biomarkers only on any rash development (\>= Grade 1) as decided by clinical judgment of the Investigator and/or dermatologist.

    Time frame: Up to the end of study (Up to 369 days)

  4. Number of Participants With Abnormalities in Immunohistochemical Examination of Blood Biomarkers

    Blood samples were to be collected along with each skin biopsy sample for immunohistochemical examination of blood biomarkers only on any rash development (\>= Grade 1) as decided by clinical judgment of the Investigator and/or dermatologist.

    Time frame: Up to the end of study (Up to 369 days)

  5. Change From Baseline in Plasma Cytokines Over Time

    Blood samples were collected for assessment of plasma cytokines biomarkers which included Tumor Necrosis Factor (TNF), Interleukin 1 beta (IL-1 beta), IL-6, IL-10, Interferon gamma (INF gamma), IL-12, IL-13, IL-2, IL-4 and IL-8. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value. Absolute values below the lower limit of quantification (LLQ) were imputed with half the LLQ and those above the upper limit of quantification (ULQ) were imputed with the ULQ.

    Time frame: Baseline (Day -1) and Session 1: Day 1 (predose, 1,3,6 hours), Day 2, Day 3 (predose, 1,3,6 hours), Day 4, Day 5; Session 2 to 6: Day -2, Day 1 (predose, 1,3,6 hours), Day 2, Day 3 (predose, 1,3,6 hours), Day 4, Day 5

  6. Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time

    Blood samples were collected for assessment of Fluid Phase Complement Markers which included complement 3 (C3). Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.

    Time frame: Baseline (Day -1) and Session 1 to 6: Day 1 (predose, 2,4,8 hours), Day 2, Day 3 (predose, 2,4,8 hours), Day 5, Day 6

  7. Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time

    Blood samples were collected for assessment of Fluid Phase Complement Markers which included complement 4 (C4). Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.

    Time frame: Baseline (Day -1) and Day 2, Day 5, Day 6

  8. Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time

    Blood samples were collected for assessment of Fluid Phase Complement Markers which included total complement (CH50). Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.

    Time frame: Baseline (Day -1) and Session 1 to 6: Day 1 (predose, 2,4,8 hours), Day 2, Day 3 (predose, 2,4,8 hours), Day 5, Day 6

  9. Change From Baseline in Inflammatory Biomarkers Over Time

    Blood samples were collected for assessment of inflammatory biomarkers which included C-Reactive protein (CRP), high-sensitivity C-reactive protein (hsCRP), serum amyloid A protein (SAA). Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.

    Time frame: Baseline (Day -1) and Session 1 to 6: Day 1 (predose, 2,4,8 hours), Day 2, Day 3 (predose, 2,4,8 hours), Day 5, Day 6

  10. Maximum Concentration (Cmax) of GSK2398852

    Blood samples were collected for evaluation of Pharmacokinetic (PK) parameters including Cmax at indicated time points. Geometric mean and geometric coefficient of variation of Cmax is presented.

    Time frame: Session 1 to 6: Day 1 (Pre-dose, 6, 8, 12 hour), Day 2, Day 3 (Pre-dose and at 6 hour), Day 4, Day 7 and Day 11

  11. Time Associated With Cmax (Tmax) of GSK2398852

    Blood samples were collected for evaluation of PK parameters including Tmax at indicated time points. Median and full range of Tmax is presented.

    Time frame: Session 1 to 6: Day 1 (Pre-dose, 6, 8, 12 hour), Day 2, Day 3 (Pre-dose and at 6 hour), Day 4, Day 7 and Day 11

  12. Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC 0-t) of GSK2398852

    Blood samples were collected for evaluation of PK parameters including AUC 0-t at indicated time points. Geometric mean and geometric coefficient of variation of AUC0-t is presented.

    Time frame: Session 1 to 6: Day 1 (Pre-dose, 6, 8, 12 hour), Day 2, Day 3 (Pre-dose and at 6 hour), Day 4, Day 7 and Day 11

  13. Cmax of GSK2315698 for Newly Diagnosed Mayo Stage II/IIIa AL Amyloidosis Participants

    Blood samples were planned to be collected for evaluation of PK parameters including Cmax at indicated time points for GSK2315698 for newly diagnosed Mayo stage II/IIIa AL Amyloidosis participants. However, no participant was enrolled in 'Group 3: Newly diagnosed Mayo stage II/IIIa AL participants.'

    Time frame: Day 1: Pre-dose; Day 2 (pre-dose and 2 hours post-dose); Day 3: Pre-dose in each session (each session of 24 days)

  14. Tmax of GSK2315698 for Newly Diagnosed Mayo Stage II/IIIa AL Amyloidosis Participants

    Blood samples were planned to be collected for evaluation of PK parameters including Tmax at indicated time points for GSK2315698 for newly diagnosed Mayo stage II/IIIa AL Amyloidosis participants. However, no participant was enrolled in 'Group 3: Newly diagnosed Mayo stage II/IIIa AL participants'.

    Time frame: Day 1: Pre-dose; Day 2: pre-dose and 2 hours post-dose; Day 3: Pre-dose in each session (each session of 24 days)

  15. AUC 0-t of GSK2315698 for Newly Diagnosed Mayo Stage II/IIIa AL Amyloidosis Participants

    Blood samples were planned to be collected for evaluation of PK parameters including AUC0-t at indicated time points for GSK2315698 for newly diagnosed Mayo stage II/IIIa AL Amyloidosis participants. However, no participant was enrolled in 'Group 3: Newly diagnosed Mayo stage II/IIIa AL participants'.

    Time frame: Day 1: Pre-dose; Day 2 (pre-dose and 2 hours post-dose); Day 3: Pre-dose in each session (each session of 24 days)

  16. Change From Baseline in Global Longitudinal Strain (GLS) by CMR

    Global Longitudinal Strain was measured by CMR at indicated time points. GLS included feature tracking and tagging by CMR. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.

    Time frame: Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-up

  17. Change From Baseline in GLS by ECHO

    Global Longitudinal Strain was measured by ECHO at indicated time points. GLS included speckle tracking by ECHO. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.

    Time frame: Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-up

  18. Change From Baseline in LV Twist Over Time

    LV twist was measured by CMR at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.

    Time frame: Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-up

  19. Change From Baseline in Stroke Volume (SV) by CMR

    Stroke volume is the amount of blood ejected by the left ventricle in one contraction. SV was measured by CMR at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.

    Time frame: Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-up

  20. Change From Baseline in SV by ECHO

    Stroke volume is the amount of blood ejected by the left ventricle in one contraction. SV was measured by ECHO at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.

    Time frame: Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-up

  21. Change From Baseline in Left Ventricular Ejection Fraction (EF) by CMR

    Left ventricular ejection fraction is a measurement of the percentage of blood leaving the heart each time it contracts. EF was measured by CMR at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.

    Time frame: Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-up

  22. Change From Baseline in Left Ventricular EF by ECHO

    Left ventricular ejection fraction is a measurement of the percentage of blood leaving the heart each time it contracts. EF was measured by ECHO at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.

    Time frame: Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-up

  23. Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by CMR

    Left ventricle EDV is the volume of blood in the left ventricle at end load or filling in (diastole) or the amount of blood in the ventricles just before systole. EDV was measured by CMR at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.

    Time frame: Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-up

  24. Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by ECHO

    Left ventricle EDV is the volume of blood in the left ventricle at end load or filling in (diastole) or the amount of blood in the ventricles just before systole. EDV was measured by ECHO at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.

    Time frame: Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-up

  25. Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio)

    E/e' ratio was measured by ECHO at indicated time points. It had 2 separate measurements: lateral and septal. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.

    Time frame: Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-up

07

Results

Posted Oct 16, 2019

Participant flow

This was an open label, non-randomized, monthly repeat anti-serum amyloid p component (anti-SAP) treatment study in systemic amyloidosis participants with cardiac dysfunction caused by cardiac amyloidosis.

Participant flow — Overall Study
MilestoneGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis ParticipantsGroup 3: Newly Diagnosed Mayo Stage II/IIIa AL Participants
Started610
Completed600
Not completed010
Withdrew: Adverse event010

Outcome measures

PrimaryChange From Baseline in Left Ventricular (LV) Mass Over Time up to 8-week Follow-up

Left ventricular mass was measured by Cardiac Magnetic Resonance (CMR) imaging to assess reduction in cardiac amyloid load after repeated administration of anti-SAP treatment. Each CMR imaging session took approximately 45-60 minutes, with a maximum scan time inside of the scanner of 90 minutes. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value. Safety Population comprised of all participants who received at least one dose of study treatment (any dose of CPHPC \[GSK2315698\] or anti-SAP mAb \[GSK2398852\]).

Time frame:
Baseline (Day -1) and Session 2 Day 24, Session 3 Day 24, Session 4 Day 24, Session 5 Day 24, 8 Weeks Follow-up
Reported as:
Mean · Grams
Change From Baseline in Left Ventricular (LV) Mass Over Time up to 8-week Follow-up
GramsGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
Session 2, Day 24, n=6,02.505 ± 19.9174—
Session 3, Day 24, n=6,04.175 ± 22.9366—
Session 4, Day 24, n=5,09.194 ± 14.4271—
Session 5, Day 24, n=4,07.955 ± 19.4341—
8 Weeks Follow up, n=6,10.977 ± 12.1795-32.420 ± NA
PrimaryNumber of Participants With Any On-treatment Adverse Events (AEs)

AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with any on-treatment AEs are presented.

Time frame:
Up to 56 days after the last dosing session (up to 265 days)
Reported as:
Count of participants · Participants
Number of Participants With Any On-treatment Adverse Events (AEs)
ParticipantsGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
Number of Participants With Any On-treatment Adverse Events (AEs)61
PrimaryNumber of Participants With Any Serious Adverse Events (SAEs)

AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, events associated with liver injury and impaired liver function, or any other situation according to medical or scientific judgment were categorized as SAE. Number of participants with any SAEs during study are presented.

Time frame:
Up to the end of study (Up to 369 days)
Reported as:
Count of participants · Participants
Number of Participants With Any Serious Adverse Events (SAEs)
ParticipantsGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
Number of Participants With Any Serious Adverse Events (SAEs)21
PrimaryNumber of Participants With Abnormal Hematology Values

Blood samples were collected for assessment of hematology parameters, which included platelet count, hemoglobin, hematocrit, erythrocytes, reticulocyte count, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), neutrophils, lymphocytes, monocytes, eosinophils, leukocytes and basophils. Abnormal laboratory results are categorized as high, low or normal with respect to their normal ranges. Data for worst case post Baseline is presented. Participants having both High and Low values from Normal Ranges at any post-baseline visits for any parameter was counted in both the High and Low categories.

Time frame:
Up to the end of study (Up to 369 days)
Reported as:
Count of participants · Participants
Number of Participants With Abnormal Hematology Values
ParticipantsGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
Basophils, high20
Basophils, normal41
Basophils, low00
Eosinophils, high30
Eosinophils, normal31
Eosinophils, low00
Hematocrit, high00
Hematocrit, normal10
Hematocrit, low51
Hemoglobin, high00
Hemoglobin, normal00
Hemoglobin, low61
Lymphocytes, high10
Lymphocytes, normal00
Lymphocytes, low61
MCH, high10
MCH, normal31
MCH, low30
MCHC, high30
MCHC, normal11
MCHC, low20
MCV, high10
MCV, normal41
MCV, low20
Monocytes, high21
Monocytes, normal40
Monocytes, low00
Neutrophils, high51
Neutrophils, normal00
Neutrophils, low40
Platelet count, high10
Platelet count, normal30
Platelet count, low21
Erythrocytes, high00
Erythrocytes, normal00
Erythrocytes, low61
Reticulocytes, high10
Reticulocytes, normal51
Reticulocytes, low00
Leukocytes, high21
Leukocytes, normal30
Leukocytes, low10
PrimaryNumber of Participants With Abnormal Clinical Chemistry Values

Blood samples were collected for assessment of clinical chemistry parameters, which included aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), urea, creatinine, glucose, chloride, creatinine kinase, potassium, sodium, calcium, total carbon dioxide (CO2), urate, total and direct bilirubin, total protein and albumin. Abnormal laboratory results are categorized as high, low or normal with respect to their normal ranges. Data for worst case post Baseline is presented. Participants having both High and Low values from Normal Ranges at any post-baseline visits for any parameter was counted in both the High and Low categories.

Time frame:
Up to the end of study (Up to 369 days)
Reported as:
Count of participants · Participants
Number of Participants With Abnormal Clinical Chemistry Values
ParticipantsGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
Glucose, high61
Glucose, normal00
Glucose, low00
Albumin, high00
Albumin, normal21
Albumin, low40
ALP, high50
ALP, normal11
ALP, low00
ALT, high21
ALT, normal40
ALT, low00
AST, high41
AST, normal20
AST, low00
Direct Bilirubin, high41
Direct Bilirubin, normal20
Direct Bilirubin, low00
Total Bilirubin, high40
Total Bilirubin, normal21
Total Bilirubin, low00
Calcium, high00
Calcium, normal40
Calcium, low21
Creatinine Kinase, high10
Creatinine Kinase, normal31
Creatinine Kinase, low20
Chloride, high00
Chloride, normal10
Chloride, low51
CO2, high60
CO2, normal01
CO2, low40
Creatinine, high40
Creatinine, normal21
Creatinine, low00
Potassium, high20
Potassium, normal31
Potassium, low20
LDH, high61
LDH, normal00
LDH, low00
Protein, high00
Protein, normal00
Protein, low61
Sodium, high10
Sodium, normal51
Sodium, low00
Urate, high51
Urate, normal10
Urate, low00
Urea, high61
Urea, normal00
Urea, low00
PrimaryNumber of Participants With Abnormal Urinalysis Results

Urine samples were collected to assess potential of hydrogen (pH), specific gravity, albumin excretion rate, creatinine excretion rate and protein excretion rate. Abnormal urinalysis results are categorized as high, low or normal with respect to their normal ranges. Data for worst case post Baseline is presented. Participants having both High and Low values from Normal Ranges at any post-baseline visits for any parameter was counted in both the High and Low categories.

Time frame:
Up to the end of study (Up to 369 days)
Reported as:
Count of participants · Participants
Number of Participants With Abnormal Urinalysis Results
ParticipantsGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
pH, high, n=6,100
pH, normal, n=6,161
pH, low, n=6,100
Specific gravity, high, n=1,00—
Specific gravity, normal, n=1,01—
Specific gravity, low, n=1,00—
Albumin excretion rate, high, n=6,100
Albumin excretion rate, normal, n=6,161
Albumin excretion rate, low, n=6,100
Creatinine excretion rate, high, n=6,110
Creatinine excretion rate, normal, n=6,111
Creatinine excretion rate, low, n=6,150
Protein excretion rate, high, n=6,141
Protein excretion rate, normal, n=6,120
Protein excretion rate, low, n=6,100
PrimaryNumber of Participants With Abnormal Urinalysis Results for Character Parameters

Urine samples were collected to assess character parameters which included Cellular Casts, Erythrocytes, Glucose, Ketones, Leukocytes and Occult Blood. Number of participants with abnormal urinalysis results are presented. Data for worst case post Baseline is presented.

Time frame:
Up to the end of study (Up to 369 days)
Reported as:
Count of participants · Participants
Number of Participants With Abnormal Urinalysis Results for Character Parameters
ParticipantsGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
Cellular casts, n=5,100
Erythrocytes , n=6,161
Glucose, n=6,110
Ketones, n=6,100
Leukocytes, n=6,161
Occult blood, n=6,121
PrimaryNumber of Participants With Body Temperature Shifts From Baseline Relative to Potential Clinical Importance (PCI) Criteria

Vital signs including body temperature was measured after participants rested in semi-supine position for at least 5 minutes. Number of participants with shifts in body temperature from Baseline to worst case post Baseline relative to PCI criteria have been presented. PCI results were categorized as to high, to low and to normal/no change with reference to PCI criteria. PCI criteria for body temperature was: high: \>37.5 degree Celsius; low: not applicable.

Time frame:
Up to the end of study (Up to 369 days)
Reported as:
Count of participants · Participants
Number of Participants With Body Temperature Shifts From Baseline Relative to Potential Clinical Importance (PCI) Criteria
ParticipantsGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
To high20
To normal/No change41
To low00
PrimaryNumber of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Shifts From Baseline Relative to PCI Criteria

Vital signs including SBP and DBP were measured after participants rested in semi-supine position for at least 5 minutes. Number of participants with shifts in SBP and DBP from baseline to worst case post baseline relative to PCI criteria have been presented. PCI results were categorized as to high, to low and to normal/no change with reference to PCI criteria. PCI criteria for SBP was: high: \>180 millimeter of mercury (mmHg); low: \<90 mmHg. PCI criteria for DBP was: high: \>110 mmHg; low: \<30 mmHg.

Time frame:
Up to the end of study (Up to 369 days)
Reported as:
Count of participants · Participants
Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Shifts From Baseline Relative to PCI Criteria
ParticipantsGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
SBP, To high00
SBP, To normal/No change11
SBP, To low50
DBP, To high00
DBP, To normal/No change61
DBP, To low00
PrimaryNumber of Participants With Pulse Rate Shifts From Baseline Relative to PCI Criteria

Vital signs including pulse rate were measured after participants rested in semi-supine position for at least 5 minutes. Number of participants with shifts in pulse rate from baseline to worst case post baseline relative to PCI criteria have been presented. PCI results were categorized as to high, to low and to normal/no change with reference to its PCI criteria. PCI criteria for pulse rate was: high: \>140 beats per minute (bpm); low: \<35 bpm.

Time frame:
Up to the end of study (Up to 369 days)
Reported as:
Count of participants · Participants
Number of Participants With Pulse Rate Shifts From Baseline Relative to PCI Criteria
ParticipantsGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
To high00
To normal/No change61
To low00
PrimaryNumber of Participants With Abnormal Electrocardiogram (ECG) Findings

Twelve-lead ECGs were performed during the study using an automated ECG machine. The number of participants with worst case post-Baseline abnormal ECG findings were reported and categorized as abnormal-clinically significant and abnormal-not clinically significant.

Time frame:
Up to the end of study (Up to 369 days)
Reported as:
Count of participants · Participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
ParticipantsGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
Abnormal-Clinically significant00
Abnormal-Not Clinically significant61
PrimaryNumber of Participants With Abnormalities During Cardiac Monitoring

Lead II telemetry and cardiac monitoring devices were used for electrical cardiac monitoring during the study. The number of participants with worst case post-Baseline abnormalities during cardiac monitoring as per investigator's assessment have been reported and categorized as Abnormal-clinically significant and Abnormal-not clinically significant.

Time frame:
Up to the end of study (Up to 369 days)
Reported as:
Count of participants · Participants
Number of Participants With Abnormalities During Cardiac Monitoring
ParticipantsGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
Abnormal-Clinically significant20
Abnormal-Not Clinically significant31
PrimaryNumber of Participants for Which Unscheduled Echocardiography (ECHO) Was Performed for Safety Reasons

Echocardiography was performed by a qualified echocardiographer or cardiologist during the study. Number of participants with unscheduled echocardiograms performed for safety reasons have been presented.

Time frame:
Up to the end of study (Up to 369 days)
Reported as:
Count of participants · Participants
Number of Participants for Which Unscheduled Echocardiography (ECHO) Was Performed for Safety Reasons
ParticipantsGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
Number of Participants for Which Unscheduled Echocardiography (ECHO) Was Performed for Safety Reasons2—
PrimaryNumber of Participants With Skin Rashes

Skin rash was an event of special interest. Only Rashes that were associated with study drug were categorised as Rash for Common Terminology Criteria for Adverse Events (CTCAE) and are presented. Number of participants with on-treatment skin rash AEs are presented.

Time frame:
Up to 56 days after the last dosing session (up to 265 days)
Reported as:
Count of participants · Participants
Number of Participants With Skin Rashes
ParticipantsGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
Number of Participants With Skin Rashes40
PrimaryNumber of Participants With Skin Rashes Classified Using CTCAE

Skin rash was an event of special interest. All the events of rashes were graded for their severity using CTCAE version 4.0 . Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life threatening, Grade 5: death. Higher the grade, more severe the symptoms. Only Rashes that were associated with study drug were categorised as Rash for CTCAE and are presented here. Number of participants with skin rashes classified by their maximum grade are presented.

Time frame:
Up to 56 days after the last dosing session (up to 265 days)
Reported as:
Count of participants · Participants
Number of Participants With Skin Rashes Classified Using CTCAE
ParticipantsGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
Grade 13—
Grade 21—
Grade 30—
Grade 40—
Grade 50—
SecondaryNumber of Participants With Abnormalities in Histopathological Examination of Skin Biopsies

Skin biopsy samples were collected for histopathological examination only on any rash development (\>= Grade 1) as decided by clinical judgment of the Investigator and/or dermatologist. Number of participants with abnormalities in histopathological examination of skin biopsies are presented.

Time frame:
Up to the end of study (Up to 369 days)
Reported as:
Count of participants · Participants
Number of Participants With Abnormalities in Histopathological Examination of Skin Biopsies
ParticipantsGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
Number of Participants With Abnormalities in Histopathological Examination of Skin Biopsies20
SecondaryNumber of Participants With Abnormalities in Immunohistochemical Examination of Skin Biopsies

Skin biopsy samples were collected for immunohistochemical examination only on any rash development (\>= Grade 1) as decided by clinical judgment of the Investigator and/or dermatologist. Number of participants with abnormalities in immunohistochemical examination of skin biopsies are presented.

Time frame:
Up to the end of study (Up to 369 days)
Reported as:
Count of participants · Participants
Number of Participants With Abnormalities in Immunohistochemical Examination of Skin Biopsies
ParticipantsGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
Number of Participants With Abnormalities in Immunohistochemical Examination of Skin Biopsies20
SecondaryNumber of Participants With Abnormalities in Histopathological Examination of Blood Biomarkers

Blood samples were to be collected along with each skin biopsy sample for histopathological examination of blood biomarkers only on any rash development (\>= Grade 1) as decided by clinical judgment of the Investigator and/or dermatologist.

Time frame:
Up to the end of study (Up to 369 days)

No measurements were reported for this outcome.

SecondaryNumber of Participants With Abnormalities in Immunohistochemical Examination of Blood Biomarkers

Blood samples were to be collected along with each skin biopsy sample for immunohistochemical examination of blood biomarkers only on any rash development (\>= Grade 1) as decided by clinical judgment of the Investigator and/or dermatologist.

Time frame:
Up to the end of study (Up to 369 days)

No measurements were reported for this outcome.

SecondaryChange From Baseline in Plasma Cytokines Over Time

Blood samples were collected for assessment of plasma cytokines biomarkers which included Tumor Necrosis Factor (TNF), Interleukin 1 beta (IL-1 beta), IL-6, IL-10, Interferon gamma (INF gamma), IL-12, IL-13, IL-2, IL-4 and IL-8. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value. Absolute values below the lower limit of quantification (LLQ) were imputed with half the LLQ and those above the upper limit of quantification (ULQ) were imputed with the ULQ.

Time frame:
Baseline (Day -1) and Session 1: Day 1 (predose, 1,3,6 hours), Day 2, Day 3 (predose, 1,3,6 hours), Day 4, Day 5; Session 2 to 6: Day -2, Day 1 (predose, 1,3,6 hours), Day 2, Day 3 (predose, 1,3,6 hours), Day 4, Day 5
Reported as:
Mean · Nanograms per liter (ng/L)
Change From Baseline in Plasma Cytokines Over Time
Nanograms per liter (ng/L)Group 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
IL-1 beta, Session 1, Day 1, predose, n=6,10.000 ± 0.00000.000 ± NA
IL-1 beta, Session 1, Day 1, 1 hour, n=6,10.000 ± 0.00000.000 ± NA
IL-1 beta, Session 1, Day 1, 3 hour, n=6,10.000 ± 0.00000.000 ± NA
IL-1 beta, Session 1, Day 1, 6 hour, n=6,10.000 ± 0.00000.000 ± NA
IL-1 beta, Session 1, Day 2, n=6,10.000 ± 0.00000.000 ± NA
IL-1 beta, Session 1, Day 3, predose, n=6,10.000 ± 0.00000.000 ± NA
IL-1 beta, Session 1, Day 3, 1 hour, n=6,00.000 ± 0.0000—
IL-1 beta, Session 1, Day 3, 3 hour, n=6,00.000 ± 0.0000—
IL-1 beta, Session 1, Day 3, 6 hour, n=6,00.000 ± 0.0000—
IL-1 beta, Session 1, Day 4, n=6,00.000 ± 0.0000—
IL-1 beta, Session 1, Day 5, n=6,00.000 ± 0.0000—
IL-1 beta, Session 2, Day -2, n=6,00.000 ± 0.0000—
IL-1 beta, Session 2, Day 1, predose, n=6,00.000 ± 0.0000—
IL-1 beta, Session 2, Day 1, 1 hour, n=6,00.000 ± 0.0000—
IL-1 beta, Session 2, Day 1, 3 hour, n=6,00.000 ± 0.0000—
IL-1 beta, Session 2, Day 1, 6 hour, n=6,00.000 ± 0.0000—
IL-1 beta, Session 2, Day 2, n=6,00.000 ± 0.0000—
IL-1 beta, Session 2, Day 3, predose, n=6,00.000 ± 0.0000—
IL-1 beta, Session 2, Day 3, 1 hour, n=6,00.000 ± 0.0000—
IL-1 beta, Session 2, Day 3, 3 hour, n=6,00.000 ± 0.0000—
IL-1 beta, Session 2, Day 3, 6 hour, n=6,00.000 ± 0.0000—
IL-1 beta, Session 2, Day 4, n=6,00.000 ± 0.0000—
IL-1 beta, Session 2, Day 5, n=6,00.000 ± 0.0000—
IL-1 beta, Session 3, Day -2, n=5,00.000 ± 0.0000—
IL-1 beta, Session 3, Day 1, predose, n=6,00.000 ± 0.0000—
IL-1 beta, Session 3, Day 1, 1 hour, n=6,00.000 ± 0.0000—
IL-1 beta, Session 3, Day 1, 3 hour, n=6,00.000 ± 0.0000—
IL-1 beta, Session 3, Day 1, 6 hour, n=6,00.000 ± 0.0000—
IL-1 beta, Session 3, Day 2, n=5,00.000 ± 0.0000—
IL-1 beta, Session 3, Day 3, predose, n=6,00.000 ± 0.0000—
IL-1 beta, Session 3, Day 3, 1 hour, n=6,00.293 ± 0.7185—
IL-1 beta, Session 3, Day 3, 3 hour, n=6,00.000 ± 0.0000—
IL-1 beta, Session 3, Day 3, 6 hour, n=6,00.000 ± 0.0000—
IL-1 beta, Session 3, Day 4, n=6,00.000 ± 0.0000—
IL-1 beta, Session 3, Day 5, n=6,00.000 ± 0.0000—
IL-1 beta, Session 4, Day -2, n=5,00.000 ± 0.0000—
IL-1 beta, Session 4, Day 1, predose, n=5,00.000 ± 0.0000—
IL-1 beta, Session 4, Day 1, 1 hour, n=5,00.000 ± 0.0000—
IL-1 beta, Session 4, Day 1, 3 hour, n=5,00.000 ± 0.0000—
IL-1 beta, Session 4, Day 1, 6 hour, n=5,00.000 ± 0.0000—
IL-1 beta, Session 4, Day 2, n=5,00.000 ± 0.0000—
IL-1 beta, Session 4, Day 3, predose, n=5,00.000 ± 0.0000—
IL-1 beta, Session 4, Day 3, 1 hour, n=5,00.000 ± 0.0000—
IL-1 beta, Session 4, Day 3, 3 hour, n=5,00.000 ± 0.0000—
IL-1 beta, Session 4, Day 3, 6 hour, n=5,00.000 ± 0.0000—
IL-1 beta, Session 4, Day 4, n=5,00.504 ± 1.1270—
IL-1 beta, Session 4, Day 5, n=4,00.000 ± 0.0000—
IL-1 beta, Session 5, Day -2, n=4,00.000 ± 0.0000—
IL-1 beta, Session 5, Day 1, predose, n=4,00.000 ± 0.0000—
IL-1 beta, Session 5, Day 1, 1 hour, n=4,00.000 ± 0.0000—
IL-1 beta, Session 5, Day 1, 3 hour, n=4,00.000 ± 0.0000—
IL-1 beta, Session 5, Day 1, 6 hour, n=4,00.000 ± 0.0000—
IL-1 beta, Session 5, Day 2, n=4,00.000 ± 0.0000—
IL-1 beta, Session 5, Day 3, predose, n=4,00.000 ± 0.0000—
IL-1 beta, Session 5, Day 3, 1 hour, n=4,00.000 ± 0.0000—
IL-1 beta, Session 5, Day 3, 3 hour, n=4,00.000 ± 0.0000—
IL-1 beta, Session 5, Day 3, 6 hour, n=4,00.000 ± 0.0000—
IL-1 beta, Session 5, Day 4, n=4,00.000 ± 0.0000—
IL-1 beta, Session 5, Day 5, n=4,00.000 ± 0.0000—
IL-1 beta, Session 6, Day -2, n=4,00.000 ± 0.0000—
IL-1 beta, Session 6, Day 1, predose, n=4,00.000 ± 0.0000—
IL-1 beta, Session 6, Day 1, 1 hour, n=4,00.000 ± 0.0000—
IL-1 beta, Session 6, Day 1, 3 hour, n=4,00.000 ± 0.0000—
IL-1 beta, Session 6, Day 1, 6 hour, n=4,00.000 ± 0.0000—
IL-1 beta, Session 6, Day 2, n=4,00.000 ± 0.0000—
IL-1 beta, Session 6, Day 3, predose, n=4,00.000 ± 0.0000—
IL-1 beta, Session 6, Day 3, 1 hour, n=4,00.000 ± 0.0000—
IL-1 beta, Session 6, Day 3, 3 hour, n=4,00.000 ± 0.0000—
IL-1 beta, Session 6, Day 3, 6 hour, n=4,00.000 ± 0.0000—
IL-1 beta, Session 6, Day 4, n=4,00.000 ± 0.0000—
IL-1 beta, Session 6, Day 5, n=4,00.000 ± 0.0000—
IL-6, Session 1, Day 1, predose, n=6,10.275 ± 0.47110.000 ± NA
IL-6, Session 1, Day 1, 1 hour, n=6,1-0.080 ± 0.77230.000 ± NA
IL-6, Session 1, Day 1, 3 hour, n=6,1-0.727 ± 1.20350.000 ± NA
IL-6, Session 1, Day 1, 6 hour, n=6,1-1.077 ± 1.25112.880 ± NA
IL-6, Session 1, Day 2, n=6,16.278 ± 6.356729.030 ± NA
IL-6, Session 1, Day 3, predose, n=6,17.688 ± 8.863916.980 ± NA
IL-6, Session 1, Day 3, 1 hour, n=6,06.857 ± 10.5934—
IL-6, Session 1, Day 3, 3 hour, n=6,00.827 ± 3.5790—
IL-6, Session 1, Day 3, 6 hour, n=6,00.932 ± 5.5637—
IL-6, Session 1, Day 4, n=6,05.453 ± 3.6039—
IL-6, Session 1, Day 5, n=6,03.245 ± 3.3934—
IL-6, Session 2, Day -2, n=6,00.393 ± 0.5250—
IL-6, Session 2, Day 1, predose, n=6,00.632 ± 1.2026—
IL-6, Session 2, Day 1, 1 hour, n=6,00.025 ± 0.7117—
IL-6, Session 2, Day 1, 3 hour, n=6,0-0.860 ± 1.0909—
IL-6, Session 2, Day 1, 6 hour, n=6,0-0.282 ± 1.7148—
IL-6, Session 2, Day 2, n=6,021.590 ± 27.1214—
IL-6, Session 2, Day 3, predose, n=6,011.365 ± 11.4140—
IL-6, Session 2, Day 3, 1 hour, n=6,07.517 ± 8.6084—
IL-6, Session 2, Day 3, 3 hour, n=6,03.460 ± 5.0176—
IL-6, Session 2, Day 3, 6 hour, n=6,00.723 ± 4.5392—
IL-6, Session 2, Day 4, n=6,04.580 ± 5.9326—
IL-6, Session 2, Day 5, n=6,06.395 ± 5.2800—
IL-6, Session 3, Day -2, n=5,00.148 ± 0.8211—
IL-6, Session 3, Day 1, predose, n=6,00.782 ± 1.5023—
IL-6, Session 3, Day 1, 1 hour, n=6,00.268 ± 1.4865—
IL-6, Session 3, Day 1, 3 hour, n=6,00.062 ± 2.5899—
IL-6, Session 3, Day 1, 6 hour, n=6,0-0.918 ± 1.2591—
IL-6, Session 3, Day 2, n=5,017.608 ± 29.2558—
IL-6, Session 3, Day 3, predose, n=6,011.872 ± 8.7413—
IL-6, Session 3, Day 3, 1 hour, n=6,05.835 ± 3.8271—
IL-6, Session 3, Day 3, 3 hour, n=6,01.742 ± 1.9174—
IL-6, Session 3, Day 3, 6 hour, n=6,00.063 ± 2.2072—
IL-6, Session 3, Day 4, n=6,04.667 ± 6.9875—
IL-6, Session 3, Day 5, n=6,05.570 ± 2.6004—
IL-6, Session 4, Day -2, n=5,00.892 ± 0.8423—
IL-6, Session 4, Day 1, predose, n=5,01.486 ± 0.8702—
IL-6, Session 4, Day 1, 1 hour, n=5,00.926 ± 0.7103—
IL-6, Session 4, Day 1, 3 hour, n=5,0-0.026 ± 0.1599—
IL-6, Session 4, Day 1, 6 hour, n=5,0-1.028 ± 1.3685—
IL-6, Session 4, Day 2, n=5,05.720 ± 11.3851—
IL-6, Session 4, Day 3, predose, n=5,010.924 ± 6.5370—
IL-6, Session 4, Day 3, 1 hour, n=5,04.486 ± 2.0420—
IL-6, Session 4, Day 3, 3 hour, n=5,01.446 ± 1.5368—
IL-6, Session 4, Day 3, 6 hour, n=5,0-0.116 ± 1.7948—
IL-6, Session 4, Day 4, n=5,05.756 ± 6.8645—
IL-6, Session 4, Day 5, n=4,04.388 ± 3.7765—
IL-6, Session 5, Day -2, n=4,00.027 ± 0.8164—
IL-6, Session 5, Day 1, predose, n=4,00.865 ± 0.9927—
IL-6, Session 5, Day 1, 1 hour, n=4,0-0.007 ± 1.3219—
IL-6, Session 5, Day 1, 3 hour, n=4,0-0.423 ± 1.5816—
IL-6, Session 5, Day 1, 6 hour, n=4,0-1.213 ± 1.5189—
IL-6, Session 5, Day 2, n=4,00.905 ± 4.0920—
IL-6, Session 5, Day 3, predose, n=4,07.323 ± 4.8265—
IL-6, Session 5, Day 3, 1 hour, n=4,04.240 ± 3.6214—
IL-6, Session 5, Day 3, 3 hour, n=4,0-0.125 ± 0.7543—
IL-6, Session 5, Day 3, 6 hour, n=4,0-1.390 ± 1.3301—
IL-6, Session 5, Day 4, n=4,03.598 ± 5.7476—
IL-6, Session 5, Day 5, n=4,06.533 ± 2.6812—
IL-6, Session 6, Day -2, n=4,01.383 ± 1.8535—
IL-6, Session 6, Day 1, predose, n=4,00.565 ± 1.4007—
IL-6, Session 6, Day 1, 1 hour, n=4,00.077 ± 1.1200—
IL-6, Session 6, Day 1, 3 hour, n=4,0-0.413 ± 1.4416—
IL-6, Session 6, Day 1, 6 hour, n=4,0-1.165 ± 0.9786—
IL-6, Session 6, Day 2, n=4,00.932 ± 4.0340—
IL-6, Session 6, Day 3, predose, n=4,015.008 ± 13.0010—
IL-6, Session 6, Day 3, 1 hour, n=4,010.083 ± 9.2076—
IL-6, Session 6, Day 3, 3 hour, n=4,01.435 ± 1.7505—
IL-6, Session 6, Day 3, 6 hour, n=4,0-1.005 ± 1.3522—
IL-6, Session 6, Day 4, n=4,01.740 ± 3.2649—
IL-6, Session 6, Day 5, n=4,07.190 ± 3.8811—
IL-10, Session 1, Day 1, predose, n=6,1-0.067 ± 0.16330.000 ± NA
IL-10, Session 1, Day 1, 1 hour, n=6,10.105 ± 0.16638.580 ± NA
IL-10, Session 1, Day 1, 3 hour, n=6,10.763 ± 0.48045.260 ± NA
IL-10, Session 1, Day 1, 6 hour, n=6,11.710 ± 1.47196.020 ± NA
IL-10, Session 1, Day 2, n=6,1-0.005 ± 0.24361.150 ± NA
IL-10, Session 1, Day 3, predose, n=6,10.040 ± 0.33471.280 ± NA
IL-10, Session 1, Day 3, 1 hour, n=6,00.670 ± 1.0153—
IL-10, Session 1, Day 3, 3 hour, n=6,00.065 ± 0.3896—
IL-10, Session 1, Day 3, 6 hour, n=6,00.002 ± 0.0041—
IL-10, Session 1, Day 4, n=6,0-0.067 ± 0.1633—
IL-10, Session 1, Day 5, n=6,0-0.067 ± 0.1633—
IL-10, Session 2, Day -2, n=6,0-0.067 ± 0.1633—
IL-10, Session 2, Day 1, predose, n=6,00.002 ± 0.0041—
IL-10, Session 2, Day 1, 1 hour, n=6,00.612 ± 0.8293—
IL-10, Session 2, Day 1, 3 hour, n=6,01.132 ± 1.1748—
IL-10, Session 2, Day 1, 6 hour, n=6,00.785 ± 0.5189—
IL-10, Session 2, Day 2, n=6,00.012 ± 0.2757—
IL-10, Session 2, Day 3, predose, n=6,00.233 ± 0.5618—
IL-10, Session 2, Day 3, 1 hour, n=6,00.775 ± 1.1274—
IL-10, Session 2, Day 3, 3 hour, n=6,00.782 ± 0.8451—
IL-10, Session 2, Day 3, 6 hour, n=6,00.015 ± 0.0367—
IL-10, Session 2, Day 4, n=6,0-0.005 ± 0.0122—
IL-10, Session 2, Day 5, n=6,00.110 ± 0.2122—
IL-10, Session 3, Day -2, n=5,00.032 ± 0.3422—
IL-10, Session 3, Day 1, predose, n=6,0-0.067 ± 0.1633—
IL-10, Session 3, Day 1, 1 hour, n=6,00.228 ± 0.2328—
IL-10, Session 3, Day 1, 3 hour, n=6,01.185 ± 1.1559—
IL-10, Session 3, Day 1, 6 hour, n=6,00.495 ± 0.6641—
IL-10, Session 3, Day 2, n=5,0-0.080 ± 0.1789—
IL-10, Session 3, Day 3, predose, n=6,0-0.067 ± 0.1633—
IL-10, Session 3, Day 3, 1 hour, n=6,00.450 ± 0.6048—
IL-10, Session 3, Day 3, 3 hour, n=6,00.322 ± 0.5322—
IL-10, Session 3, Day 3, 6 hour, n=6,00.092 ± 0.1542—
IL-10, Session 3, Day 4, n=6,0-0.067 ± 0.1633—
IL-10, Session 3, Day 5, n=6,0-0.067 ± 0.1633—
IL-10, Session 4, Day -2, n=5,0-0.080 ± 0.1789—
IL-10, Session 4, Day 1, predose, n=5,0-0.080 ± 0.1789—
IL-10, Session 4, Day 1, 1 hour, n=5,00.758 ± 1.4466—
IL-10, Session 4, Day 1, 3 hour, n=5,03.868 ± 6.3123—
IL-10, Session 4, Day 1, 6 hour, n=5,00.868 ± 0.9281—
IL-10, Session 4, Day 2, n=5,0-0.080 ± 0.1789—
IL-10, Session 4, Day 3, predose, n=5,00.022 ± 0.0492—
IL-10, Session 4, Day 3, 1 hour, n=5,00.808 ± 1.0592—
IL-10, Session 4, Day 3, 3 hour, n=5,00.598 ± 0.6549—
IL-10, Session 4, Day 3, 6 hour, n=5,00.184 ± 0.4284—
IL-10, Session 4, Day 4, n=5,0-0.080 ± 0.1789—
IL-10, Session 4, Day 5, n=4,0-0.100 ± 0.2000—
IL-10, Session 5, Day -2, n=4,0-0.100 ± 0.2000—
IL-10, Session 5, Day 1, predose, n=4,0-0.100 ± 0.2000—
IL-10, Session 5, Day 1, 1 hour, n=4,02.485 ± 4.8507—
IL-10, Session 5, Day 1, 3 hour, n=4,03.828 ± 6.5828—
IL-10, Session 5, Day 1, 6 hour, n=4,01.120 ± 1.5607—
IL-10, Session 5, Day 2, n=4,0-0.100 ± 0.2000—
IL-10, Session 5, Day 3, predose, n=4,00.393 ± 0.4774—
IL-10, Session 5, Day 3, 1 hour, n=4,00.950 ± 0.9330—
IL-10, Session 5, Day 3, 3 hour, n=4,01.060 ± 0.9783—
IL-10, Session 5, Day 3, 6 hour, n=4,00.663 ± 0.6663—
IL-10, Session 5, Day 4, n=4,00.210 ± 0.4267—
IL-10, Session 5, Day 5, n=4,00.025 ± 0.0500—
IL-10, Session 6, Day -2, n=4,0-0.100 ± 0.2000—
IL-10, Session 6, Day 1, predose, n=4,0-0.100 ± 0.2000—
IL-10, Session 6, Day 1, 1 hour, n=4,00.333 ± 0.9506—
IL-10, Session 6, Day 1, 3 hour, n=4,01.738 ± 2.5365—
IL-10, Session 6, Day 1, 6 hour, n=4,01.418 ± 1.7245—
IL-10, Session 6, Day 2, n=4,0-0.100 ± 0.2000—
IL-10, Session 6, Day 3, predose, n=4,00.015 ± 0.0300—
IL-10, Session 6, Day 3, 1 hour, n=4,00.753 ± 1.4004—
IL-10, Session 6, Day 3, 3 hour, n=4,00.675 ± 1.1466—
IL-10, Session 6, Day 3, 6 hour, n=4,00.220 ± 0.2723—
IL-10, Session 6, Day 4, n=4,0-0.100 ± 0.2000—
IL-10, Session 6, Day 5, n=4,00.023 ± 0.0450—
TNF, Session 1, Day 1, predose, n=6,10.055 ± 0.43780.320 ± NA
TNF, Session 1, Day 1, 1 hour, n=6,10.007 ± 0.71590.100 ± NA
TNF, Session 1, Day 1, 3 hour, n=6,1-0.180 ± 0.74300.880 ± NA
TNF, Session 1, Day 1, 6 hour, n=6,1-0.132 ± 0.81452.300 ± NA
TNF, Session 1, Day 2, n=6,11.920 ± 1.53795.130 ± NA
TNF, Session 1, Day 3, predose, n=6,11.453 ± 1.34053.010 ± NA
TNF, Session 1, Day 3, 1 hour, n=6,01.240 ± 0.9968—
TNF, Session 1, Day 3, 3 hour, n=6,00.797 ± 1.0229—
TNF, Session 1, Day 3, 6 hour, n=6,00.460 ± 0.9373—
TNF, Session 1, Day 4, n=6,01.088 ± 1.2874—
TNF, Session 1, Day 5, n=6,01.577 ± 1.5915—
TNF, Session 2, Day -2, n=6,00.167 ± 0.9735—
TNF, Session 2, Day 1, predose, n=6,00.233 ± 0.8351—
TNF, Session 2, Day 1, 1 hour, n=6,00.133 ± 1.0259—
TNF, Session 2, Day 1, 3 hour, n=6,00.015 ± 1.0940—
TNF, Session 2, Day 1, 6 hour, n=6,0-0.100 ± 1.2625—
TNF, Session 2, Day 2, n=6,01.523 ± 1.6646—
TNF, Session 2, Day 3, predose, n=6,02.143 ± 1.5642—
TNF, Session 2, Day 3, 1 hour, n=6,01.682 ± 1.3855—
TNF, Session 2, Day 3, 3 hour, n=6,01.133 ± 0.9970—
TNF, Session 2, Day 3, 6 hour, n=6,00.503 ± 1.0718—
TNF, Session 2, Day 4, n=6,01.397 ± 2.1712—
TNF, Session 2, Day 5, n=6,01.968 ± 1.4560—
TNF, Session 3, Day -2, n=5,00.098 ± 1.2163—
TNF, Session 3, Day 1, predose, n=6,00.497 ± 0.9650—
TNF, Session 3, Day 1, 1 hour, n=6,0-0.297 ± 0.9572—
TNF, Session 3, Day 1, 3 hour, n=6,0-0.198 ± 0.9246—
TNF, Session 3, Day 1, 6 hour, n=6,0-0.167 ± 1.2317—
TNF, Session 3, Day 2, n=5,00.446 ± 1.1212—
TNF, Session 3, Day 3, predose, n=6,01.267 ± 1.1583—
TNF, Session 3, Day 3, 1 hour, n=6,00.513 ± 1.1234—
TNF, Session 3, Day 3, 3 hour, n=6,00.128 ± 1.0706—
TNF, Session 3, Day 3, 6 hour, n=6,00.233 ± 1.2605—
TNF, Session 3, Day 4, n=6,00.585 ± 1.6017—
TNF, Session 3, Day 5, n=6,00.997 ± 1.3819—
TNF, Session 4, Day -2, n=5,0-0.208 ± 0.5949—
TNF, Session 4, Day 1, predose, n=5,0-0.214 ± 0.8527—
TNF, Session 4, Day 1, 1 hour, n=5,00.160 ± 1.5494—
TNF, Session 4, Day 1, 3 hour, n=5,00.218 ± 1.5011—
TNF, Session 4, Day 1, 6 hour, n=5,0-0.412 ± 1.1373—
TNF, Session 4, Day 2, n=5,0-0.122 ± 0.6977—
TNF, Session 4, Day 3, predose, n=5,00.606 ± 0.5265—
TNF, Session 4, Day 3, 1 hour, n=5,00.100 ± 0.5074—
TNF, Session 4, Day 3, 3 hour, n=5,00.098 ± 0.7172—
TNF, Session 4, Day 3, 6 hour, n=5,0-0.702 ± 0.5368—
TNF, Session 4, Day 4, n=5,0-0.270 ± 0.7576—
TNF, Session 4, Day 5, n=4,00.095 ± 0.4456—
TNF, Session 5, Day -2, n=4,0-0.350 ± 0.5814—
TNF, Session 5, Day 1, predose, n=4,0-0.320 ± 0.6703—
TNF, Session 5, Day 1, 1 hour, n=4,0-0.130 ± 1.2227—
TNF, Session 5, Day 1, 3 hour, n=4,0-0.055 ± 1.0728—
TNF, Session 5, Day 1, 6 hour, n=4,0-0.513 ± 1.1003—
TNF, Session 5, Day 2, n=4,0-0.498 ± 0.9752—
TNF, Session 5, Day 3, predose, n=4,00.147 ± 0.8951—
TNF, Session 5, Day 3, 1 hour, n=4,0-0.188 ± 0.7406—
TNF, Session 5, Day 3, 3 hour, n=4,0-0.378 ± 0.9306—
TNF, Session 5, Day 3, 6 hour, n=4,0-0.630 ± 0.7857—
TNF, Session 5, Day 4, n=4,0-0.100 ± 1.0725—
TNF, Session 5, Day 5, n=4,00.168 ± 0.3909—
TNF, Session 6, Day -2, n=4,0-0.428 ± 1.3664—
TNF, Session 6, Day 1, predose, n=4,0-0.238 ± 1.3158—
TNF, Session 6, Day 1, 1 hour, n=4,0-0.303 ± 1.3853—
TNF, Session 6, Day 1, 3 hour, n=4,0-0.145 ± 1.8684—
TNF, Session 6, Day 1, 6 hour, n=4,0-0.500 ± 1.4020—
TNF, Session 6, Day 2, n=4,0-0.000 ± 1.3253—
TNF, Session 6, Day 3, predose, n=4,00.278 ± 1.9987—
TNF, Session 6, Day 3, 1 hour, n=4,0-0.195 ± 1.6007—
TNF, Session 6, Day 3, 3 hour, n=4,0-0.385 ± 1.4669—
TNF, Session 6, Day 3, 6 hour, n=4,0-0.585 ± 1.3026—
TNF, Session 6, Day 4, n=4,0-0.368 ± 1.1280—
TNF, Session 6, Day 5, n=4,00.322 ± 1.2795—
INF gamma, Session 1, Day 1, predose, n=6,10.075 ± 1.62241.860 ± NA
INF gamma, Session 1, Day 1, 1 hour, n=6,1-1.373 ± 2.12550.000 ± NA
INF gamma, Session 1, Day 1, 3 hour, n=6,1-3.298 ± 3.14090.000 ± NA
INF gamma, Session 1, Day 1, 6 hour, n=6,1-3.298 ± 3.14090.000 ± NA
INF gamma, Session 1, Day 2, n=6,11.713 ± 7.59551.930 ± NA
INF gamma, Session 1, Day 3, predose, n=6,117.122 ± 27.39800.000 ± NA
INF gamma, Session 1, Day 3, 1 hour, n=6,012.118 ± 22.0807—
INF gamma, Session 1, Day 3, 3 hour, n=6,07.150 ± 18.4949—
INF gamma, Session 1, Day 3, 6 hour, n=6,00.538 ± 8.5114—
INF gamma, Session 1, Day 4, n=6,03.242 ± 12.2847—
INF gamma, Session 1, Day 5, n=6,019.502 ± 38.3215—
INF gamma, Session 2, Day -2, n=6,0-1.045 ± 3.4175—
INF gamma, Session 2, Day 1, predose, n=6,00.452 ± 3.5018—
INF gamma, Session 2, Day 1, 1 hour, n=6,00.145 ± 3.2180—
INF gamma, Session 2, Day 1, 3 hour, n=6,0-1.833 ± 1.3991—
INF gamma, Session 2, Day 1, 6 hour, n=6,0-3.072 ± 2.6378—
INF gamma, Session 2, Day 2, n=6,0-2.660 ± 3.5043—
INF gamma, Session 2, Day 3, predose, n=6,0-1.045 ± 2.2260—
INF gamma, Session 2, Day 3, 1 hour, n=6,0-1.580 ± 2.5672—
INF gamma, Session 2, Day 3, 3 hour, n=6,0-2.473 ± 2.5631—
INF gamma, Session 2, Day 3, 6 hour, n=6,0-3.298 ± 3.1409—
INF gamma, Session 2, Day 4, n=6,0-2.572 ± 3.4040—
INF gamma, Session 2, Day 5, n=6,0-1.993 ± 2.8977—
INF gamma, Session 3, Day -2, n=5,0-2.190 ± 3.9839—
INF gamma, Session 3, Day 1, predose, n=6,0-1.035 ± 4.4739—
INF gamma, Session 3, Day 1, 1 hour, n=6,0-2.180 ± 3.8365—
INF gamma, Session 3, Day 1, 3 hour, n=6,0-3.298 ± 3.1409—
INF gamma, Session 3, Day 1, 6 hour, n=6,0-3.298 ± 3.1409—
INF gamma, Session 3, Day 2, n=5,0-2.936 ± 3.7855—
INF gamma, Session 3, Day 3, predose, n=6,0-2.948 ± 2.3737—
INF gamma, Session 3, Day 3, 1 hour, n=6,0-3.298 ± 3.1409—
INF gamma, Session 3, Day 3, 3 hour, n=6,0-3.298 ± 3.1409—
INF gamma, Session 3, Day 3, 6 hour, n=6,0-3.298 ± 3.1409—
INF gamma, Session 3, Day 4, n=6,0-3.048 ± 3.1886—
INF gamma, Session 3, Day 5, n=6,0-2.752 ± 3.2989—
INF gamma, Session 4, Day -2, n=5,00.298 ± 5.3631—
INF gamma, Session 4, Day 1, predose, n=5,0-0.760 ± 4.2290—
INF gamma, Session 4, Day 1, 1 hour, n=5,0-1.240 ± 4.3736—
INF gamma, Session 4, Day 1, 3 hour, n=5,0-2.778 ± 3.9570—
INF gamma, Session 4, Day 1, 6 hour, n=5,0-3.274 ± 3.5110—
INF gamma, Session 4, Day 2, n=5,0-3.274 ± 3.5110—
INF gamma, Session 4, Day 3, predose, n=5,0-2.836 ± 2.6051—
INF gamma, Session 4, Day 3, 1 hour, n=5,0-3.274 ± 3.5110—
INF gamma, Session 4, Day 3, 3 hour, n=5,0-3.274 ± 3.5110—
INF gamma, Session 4, Day 3, 6 hour, n=5,0-3.274 ± 3.5110—
INF gamma, Session 4, Day 4, n=5,0-3.274 ± 3.5110—
INF gamma, Session 4, Day 5, n=4,0-2.910 ± 3.1667—
INF gamma, Session 5, Day -2, n=4,0-0.930 ± 3.5480—
INF gamma, Session 5, Day 1, predose, n=4,0-1.328 ± 2.1878—
INF gamma, Session 5, Day 1, 1 hour, n=4,0-1.423 ± 1.9828—
INF gamma, Session 5, Day 1, 3 hour, n=4,0-2.725 ± 2.8230—
INF gamma, Session 5, Day 1, 6 hour, n=4,0-3.373 ± 4.0462—
INF gamma, Session 5, Day 2, n=4,0-3.373 ± 4.0462—
INF gamma, Session 5, Day 3, predose, n=4,00.753 ± 4.9155—
INF gamma, Session 5, Day 3, 1 hour, n=4,00.203 ± 4.5195—
INF gamma, Session 5, Day 3, 3 hour, n=4,0-1.388 ± 4.8505—
INF gamma, Session 5, Day 3, 6 hour, n=4,0-2.838 ± 4.4804—
INF gamma, Session 5, Day 4, n=4,0-1.653 ± 6.0355—
INF gamma, Session 5, Day 5, n=4,0-0.615 ± 2.9091—
INF gamma, Session 6, Day -2, n=4,0-2.625 ± 4.4662—
INF gamma, Session 6, Day 1, predose, n=4,0-2.668 ± 4.4299—
INF gamma, Session 6, Day 1, 1 hour, n=4,0-2.823 ± 4.3091—
INF gamma, Session 6, Day 1, 3 hour, n=4,0-3.373 ± 4.0462—
INF gamma, Session 6, Day 1, 6 hour, n=4,0-3.373 ± 4.0462—
INF gamma, Session 6, Day 2, n=4,0-3.373 ± 4.0462—
INF gamma, Session 6, Day 3, predose, n=4,0-1.988 ± 5.0857—
INF gamma, Session 6, Day 3, 1 hour, n=4,0-3.018 ± 4.1848—
INF gamma, Session 6, Day 3, 3 hour, n=4,0-3.373 ± 4.0462—
INF gamma, Session 6, Day 3, 6 hour, n=4,0-3.373 ± 4.0462—
INF gamma, Session 6, Day 4, n=4,0-3.373 ± 4.0462—
INF gamma, Session 6, Day 5, n=4,0-3.373 ± 4.0462—
IL-12, Session 1, Day 1, predose, n=6,10.000 ± 0.00000.000 ± NA
IL-12, Session 1, Day 1, 1 hour, n=6,10.000 ± 0.00000.000 ± NA
IL-12, Session 1, Day 1, 3 hour, n=6,10.000 ± 0.00000.000 ± NA
IL-12, Session 1, Day 1, 6 hour, n=6,10.000 ± 0.00000.000 ± NA
IL-12, Session 1, Day 2, n=6,10.000 ± 0.00000.000 ± NA
IL-12, Session 1, Day 3, predose, n=6,10.000 ± 0.00000.000 ± NA
IL-12, Session 1, Day 3, 1 hour, n=6,00.000 ± 0.0000—
IL-12, Session 1, Day 3, 3 hour, n=6,00.000 ± 0.0000—
IL-12, Session 1, Day 3, 6 hour, n=6,00.000 ± 0.0000—
IL-12, Session 1, Day 4, n=6,00.000 ± 0.0000—
IL-12, Session 1, Day 5, n=6,00.000 ± 0.0000—
IL-12, Session 2, Day -2, n=6,00.000 ± 0.0000—
IL-12, Session 2, Day 1, predose, n=6,00.000 ± 0.0000—
IL-12, Session 2, Day 1, 1 hour, n=6,00.000 ± 0.0000—
IL-12, Session 2, Day 1, 3 hour, n=6,00.000 ± 0.0000—
IL-12, Session 2, Day 1, 6 hour, n=6,00.000 ± 0.0000—
IL-12, Session 2, Day 2, n=6,00.000 ± 0.0000—
IL-12, Session 2, Day 3, predose, n=6,00.000 ± 0.0000—
IL-12, Session 2, Day 3, 1 hour, n=6,00.000 ± 0.0000—
IL-12, Session 2, Day 3, 3 hour, n=6,00.000 ± 0.0000—
IL-12, Session 2, Day 3, 6 hour, n=6,00.000 ± 0.0000—
IL-12, Session 2, Day 4, n=6,00.000 ± 0.0000—
IL-12, Session 2, Day 5, n=6,00.000 ± 0.0000—
IL-12, Session 3, Day -2, n=5,00.000 ± 0.0000—
IL-12, Session 3, Day 1, predose, n=6,00.000 ± 0.0000—
IL-12, Session 3, Day 1, 1 hour, n=6,00.000 ± 0.0000—
IL-12, Session 3, Day 1, 3 hour, n=6,00.000 ± 0.0000—
IL-12, Session 3, Day 1, 6 hour, n=6,00.000 ± 0.0000—
IL-12, Session 3, Day 2, n=5,00.000 ± 0.0000—
IL-12, Session 3, Day 3, predose, n=6,00.000 ± 0.0000—
IL-12, Session 3, Day 3, 1 hour, n=6,00.000 ± 0.0000—
IL-12, Session 3, Day 3, 3 hour, n=6,00.000 ± 0.0000—
IL-12, Session 3, Day 3, 6 hour, n=6,00.000 ± 0.0000—
IL-12, Session 3, Day 4, n=6,00.000 ± 0.0000—
IL-12, Session 3, Day 5, n=6,00.000 ± 0.0000—
IL-12, Session 4, Day -2, n=5,00.000 ± 0.0000—
IL-12, Session 4, Day 1, predose, n=5,00.000 ± 0.0000—
IL-12, Session 4, Day 1, 1 hour, n=5,00.000 ± 0.0000—
IL-12, Session 4, Day 1, 3 hour, n=5,00.000 ± 0.0000—
IL-12, Session 4, Day 1, 6 hour, n=5,00.000 ± 0.0000—
IL-12, Session 4, Day 2, n=5,00.000 ± 0.0000—
IL-12, Session 4, Day 3, predose, n=5,00.000 ± 0.0000—
IL-12, Session 4, Day 3, 1 hour, n=5,00.000 ± 0.0000—
IL-12, Session 4, Day 3, 3 hour, n=5,00.000 ± 0.0000—
IL-12, Session 4, Day 3, 6 hour, n=5,00.000 ± 0.0000—
IL-12, Session 4, Day 4, n=5,00.000 ± 0.0000—
IL-12, Session 4, Day 5, n=4,00.000 ± 0.0000—
IL-12, Session 5, Day -2, n=4,00.000 ± 0.0000—
IL-12, Session 5, Day 1, predose, n=4,00.000 ± 0.0000—
IL-12, Session 5, Day 1, 1 hour, n=4,00.000 ± 0.0000—
IL-12, Session 5, Day 1, 3 hour, n=4,00.000 ± 0.0000—
IL-12, Session 5, Day 1, 6 hour, n=4,00.000 ± 0.0000—
IL-12, Session 5, Day 2, n=4,00.000 ± 0.0000—
IL-12, Session 5, Day 3, predose, n=4,00.000 ± 0.0000—
IL-12, Session 5, Day 3, 1 hour, n=4,00.000 ± 0.0000—
IL-12, Session 5, Day 3, 3 hour, n=4,00.000 ± 0.0000—
IL-12, Session 5, Day 3, 6 hour, n=4,00.000 ± 0.0000—
IL-12, Session 5, Day 4, n=4,00.000 ± 0.0000—
IL-12, Session 5, Day 5, n=4,00.000 ± 0.0000—
IL-12, Session 6, Day -2, n=4,00.000 ± 0.0000—
IL-12, Session 6, Day 1, predose, n=4,00.000 ± 0.0000—
IL-12, Session 6, Day 1, 1 hour, n=4,00.000 ± 0.0000—
IL-12, Session 6, Day 1, 3 hour, n=4,00.000 ± 0.0000—
IL-12, Session 6, Day 1, 6 hour, n=4,00.000 ± 0.0000—
IL-12, Session 6, Day 2, n=4,00.000 ± 0.0000—
IL-12, Session 6, Day 3, predose, n=4,00.000 ± 0.0000—
IL-12, Session 6, Day 3, 1 hour, n=4,00.000 ± 0.0000—
IL-12, Session 6, Day 3, 3 hour, n=4,00.000 ± 0.0000—
IL-12, Session 6, Day 3, 6 hour, n=4,00.000 ± 0.0000—
IL-12, Session 6, Day 4, n=4,00.000 ± 0.0000—
IL-12, Session 6, Day 5, n=4,00.000 ± 0.0000—
IL-13, Session 1, Day 1, predose, n=6,10.000 ± 0.00000.000 ± NA
IL-13, Session 1, Day 1, 1 hour, n=6,10.000 ± 0.00000.000 ± NA
IL-13, Session 1, Day 1, 3 hour, n=6,10.000 ± 0.00000.000 ± NA
IL-13, Session 1, Day 1, 6 hour, n=6,10.000 ± 0.00000.000 ± NA
IL-13, Session 1, Day 2, n=6,10.000 ± 0.00000.000 ± NA
IL-13, Session 1, Day 3, predose, n=6,10.000 ± 0.00000.000 ± NA
IL-13, Session 1, Day 3, 1 hour, n=6,00.000 ± 0.0000—
IL-13, Session 1, Day 3, 3 hour, n=6,00.000 ± 0.0000—
IL-13, Session 1, Day 3, 6 hour, n=6,00.000 ± 0.0000—
IL-13, Session 1, Day 4, n=6,00.000 ± 0.0000—
IL-13, Session 1, Day 5, n=6,00.000 ± 0.0000—
IL-13, Session 2, Day -2, n=6,00.000 ± 0.0000—
IL-13, Session 2, Day 1, predose, n=6,00.000 ± 0.0000—
IL-13, Session 2, Day 1, 1 hour, n=6,00.000 ± 0.0000—
IL-13, Session 2, Day 1, 3 hour, n=6,00.000 ± 0.0000—
IL-13, Session 2, Day 1, 6 hour, n=6,00.000 ± 0.0000—
IL-13, Session 2, Day 2, n=6,00.000 ± 0.0000—
IL-13, Session 2, Day 3, predose, n=6,00.000 ± 0.0000—
IL-13, Session 2, Day 3, 1 hour, n=6,00.000 ± 0.0000—
IL-13, Session 2, Day 3, 3 hour, n=6,00.000 ± 0.0000—
IL-13, Session 2, Day 3, 6 hour, n=6,00.000 ± 0.0000—
IL-13, Session 2, Day 4, n=6,00.000 ± 0.0000—
IL-13, Session 2, Day 5, n=6,00.000 ± 0.0000—
IL-13, Session 3, Day -2, n=5,00.000 ± 0.0000—
IL-13, Session 3, Day 1, predose, n=6,00.000 ± 0.0000—
IL-13, Session 3, Day 1, 1 hour, n=6,00.000 ± 0.0000—
IL-13, Session 3, Day 1, 3 hour, n=6,00.000 ± 0.0000—
IL-13, Session 3, Day 1, 6 hour, n=6,00.000 ± 0.0000—
IL-13, Session 3, Day 2, n=5,00.000 ± 0.0000—
IL-13, Session 3, Day 3, predose, n=6,00.333 ± 0.8165—
IL-13, Session 3, Day 3, 1 hour, n=6,00.000 ± 0.0000—
IL-13, Session 3, Day 3, 3 hour, n=6,00.000 ± 0.0000—
IL-13, Session 3, Day 3, 6 hour, n=6,00.000 ± 0.0000—
IL-13, Session 3, Day 4, n=6,00.000 ± 0.0000—
IL-13, Session 3, Day 5, n=6,00.000 ± 0.0000—
IL-13, Session 4, Day -2, n=5,00.000 ± 0.0000—
IL-13, Session 4, Day 1, predose, n=5,00.000 ± 0.0000—
IL-13, Session 4, Day 1, 1 hour, n=5,00.000 ± 0.0000—
IL-13, Session 4, Day 1, 3 hour, n=5,00.000 ± 0.0000—
IL-13, Session 4, Day 1, 6 hour, n=5,00.000 ± 0.0000—
IL-13, Session 4, Day 2, n=5,00.000 ± 0.0000—
IL-13, Session 4, Day 3, predose, n=5,00.000 ± 0.0000—
IL-13, Session 4, Day 3, 1 hour, n=5,00.000 ± 0.0000—
IL-13, Session 4, Day 3, 3 hour, n=5,00.000 ± 0.0000—
IL-13, Session 4, Day 3, 6 hour, n=5,00.000 ± 0.0000—
IL-13, Session 4, Day 4, n=5,00.000 ± 0.0000—
IL-13, Session 4, Day 5, n=4,00.000 ± 0.0000—
IL-13, Session 5, Day -2, n=4,00.000 ± 0.0000—
IL-13, Session 5, Day 1, predose, n=4,00.000 ± 0.0000—
IL-13, Session 5, Day 1, 1 hour, n=4,00.000 ± 0.0000—
IL-13, Session 5, Day 1, 3 hour, n=4,00.000 ± 0.0000—
IL-13, Session 5, Day 1, 6 hour, n=4,00.000 ± 0.0000—
IL-13, Session 5, Day 2, n=4,00.000 ± 0.0000—
IL-13, Session 5, Day 3, predose, n=4,00.000 ± 0.0000—
IL-13, Session 5, Day 3, 1 hour, n=4,00.283 ± 0.5650—
IL-13, Session 5, Day 3, 3 hour, n=4,00.000 ± 0.0000—
IL-13, Session 5, Day 3, 6 hour, n=4,00.000 ± 0.0000—
IL-13, Session 5, Day 4, n=4,00.000 ± 0.0000—
IL-13, Session 5, Day 5, n=4,00.000 ± 0.0000—
IL-13, Session 6, Day -2, n=4,00.000 ± 0.0000—
IL-13, Session 6, Day 1, predose, n=4,00.000 ± 0.0000—
IL-13, Session 6, Day 1, 1 hour, n=4,00.000 ± 0.0000—
IL-13, Session 6, Day 1, 3 hour, n=4,00.000 ± 0.0000—
IL-13, Session 6, Day 1, 6 hour, n=4,00.000 ± 0.0000—
IL-13, Session 6, Day 2, n=4,00.000 ± 0.0000—
IL-13, Session 6, Day 3, predose, n=4,00.000 ± 0.0000—
IL-13, Session 6, Day 3, 3 hour, n=4,00.000 ± 0.0000—
IL-13, Session 6, Day 3, 6 hour, n=4,00.000 ± 0.0000—
IL-13, Session 6, Day 4, n=4,00.488 ± 0.9750—
IL-13, Session 6, Day 5, n=4,00.000 ± 0.0000—
IL-2, Session 1, Day 1, predose, n=6,10.000 ± 0.00000.000 ± NA
IL-2, Session 1, Day 1, 1 hour, n=6,10.000 ± 0.00000.000 ± NA
IL-2, Session 1, Day 1, 3 hour, n=6,10.000 ± 0.00000.000 ± NA
IL-2, Session 1, Day 1, 6 hour, n=6,10.000 ± 0.00000.000 ± NA
IL-2, Session 1, Day 2, n=6,10.000 ± 0.00000.000 ± NA
IL-2, Session 1, Day 3, predose, n=6,10.000 ± 0.00000.000 ± NA
IL-2, Session 1, Day 3, 1 hour, n=6,00.000 ± 0.0000—
IL-2, Session 1, Day 3, 3 hour, n=6,00.000 ± 0.0000—
IL-2, Session 1, Day 3, 6 hour, n=6,00.000 ± 0.0000—
IL-2, Session 1, Day 4, n=6,00.000 ± 0.0000—
IL-2, Session 1, Day 5, n=6,00.000 ± 0.0000—
IL-2, Session 2, Day -2, n=6,00.000 ± 0.0000—
IL-2, Session 2, Day 1, predose, n=6,00.000 ± 0.0000—
IL-2, Session 2, Day 1, 1 hour, n=6,00.000 ± 0.0000—
IL-2, Session 2, Day 1, 3 hour, n=6,00.000 ± 0.0000—
IL-2, Session 2, Day 1, 6 hour, n=6,00.000 ± 0.0000—
IL-2, Session 2, Day 2, n=6,00.000 ± 0.0000—
IL-2, Session 2, Day 3, predose, n=6,00.000 ± 0.0000—
IL-2, Session 2, Day 3, 1 hour, n=6,00.000 ± 0.0000—
IL-2, Session 2, Day 3, 3 hour, n=6,00.000 ± 0.0000—
IL-2, Session 2, Day 3, 6 hour, n=6,00.000 ± 0.0000—
IL-2, Session 2, Day 4, n=6,00.000 ± 0.0000—
IL-2, Session 2, Day 5, n=6,00.000 ± 0.0000—
IL-2, Session 3, Day -2, n=5,00.000 ± 0.0000—
IL-2, Session 3, Day 1, predose, n=6,00.000 ± 0.0000—
IL-2, Session 3, Day 1, 1 hour, n=6,00.000 ± 0.0000—
IL-2, Session 3, Day 1, 3 hour, n=6,00.000 ± 0.0000—
IL-2, Session 3, Day 1, 6 hour, n=6,00.000 ± 0.0000—
IL-2, Session 3, Day 2, n=5,00.000 ± 0.0000—
IL-2, Session 3, Day 3, predose, n=6,00.000 ± 0.0000—
IL-2, Session 3, Day 3, 1 hour, n=6,00.000 ± 0.0000—
IL-2, Session 3, Day 3, 3 hour, n=6,00.000 ± 0.0000—
IL-2, Session 3, Day 3, 6 hour, n=6,00.000 ± 0.0000—
IL-2, Session 3, Day 4, n=6,00.000 ± 0.0000—
IL-2, Session 3, Day 5, n=6,00.000 ± 0.0000—
IL-2, Session 4, Day -2, n=5,00.000 ± 0.0000—
IL-2, Session 4, Day 1, predose, n=5,00.000 ± 0.0000—
IL-2, Session 4, Day 1, 1 hour, n=5,00.000 ± 0.0000—
IL-2, Session 4, Day 1, 3 hour, n=5,00.000 ± 0.0000—
IL-2, Session 4, Day 1, 6 hour, n=5,00.000 ± 0.0000—
IL-2, Session 4, Day 2, n=5,00.000 ± 0.0000—
IL-2, Session 4, Day 3, predose, n=5,00.000 ± 0.0000—
IL-2, Session 4, Day 3, 1 hour, n=5,00.000 ± 0.0000—
IL-2, Session 4, Day 3, 3 hour, n=5,00.000 ± 0.0000—
IL-2, Session 4, Day 3, 6 hour, n=5,00.000 ± 0.0000—
IL-2, Session 4, Day 4, n=5,00.000 ± 0.0000—
IL-2, Session 4, Day 5, n=4,00.000 ± 0.0000—
IL-2, Session 5, Day -2, n=4,00.000 ± 0.0000—
IL-2, Session 5, Day 1, predose, n=4,00.000 ± 0.0000—
IL-2, Session 5, Day 1, 1 hour, n=4,00.000 ± 0.0000—
IL-2, Session 5, Day 1, 3 hour, n=4,00.000 ± 0.0000—
IL-2, Session 5, Day 1, 6 hour, n=4,00.000 ± 0.0000—
IL-2, Session 5, Day 2, n=4,00.000 ± 0.0000—
IL-2, Session 5, Day 3, predose, n=4,00.000 ± 0.0000—
IL-2, Session 5, Day 3, 1 hour, n=4,00.000 ± 0.0000—
IL-2, Session 5, Day 3, 3 hour, n=4,00.000 ± 0.0000—
IL-2, Session 5, Day 3, 6 hour, n=4,00.000 ± 0.0000—
IL-2, Session 5, Day 4, n=4,00.000 ± 0.0000—
IL-2, Session 5, Day 5, n=4,00.000 ± 0.0000—
IL-2, Session 6, Day -2, n=4,00.000 ± 0.0000—
IL-2, Session 6, Day 1, predose, n=4,00.000 ± 0.0000—
IL-2, Session 6, Day 1, 1 hour, n=4,00.000 ± 0.0000—
IL-2, Session 6, Day 1, 3 hour, n=4,00.000 ± 0.0000—
IL-2, Session 6, Day 1, 6 hour, n=4,00.000 ± 0.0000—
IL-2, Session 6, Day 2, n=4,00.000 ± 0.0000—
IL-2, Session 6, Day 3, predose, n=4,00.000 ± 0.0000—
IL-2, Session 6, Day 3, 1 hour, n=4,00.000 ± 0.0000—
IL-2, Session 6, Day 3, 3 hour, n=4,00.000 ± 0.0000—
IL-2, Session 6, Day 3, 6 hour, n=4,00.000 ± 0.0000—
IL-2, Session 6, Day 4, n=4,00.000 ± 0.0000—
IL-2, Session 6, Day 5, n=4,00.000 ± 0.0000—
IL-4, Session 1, Day 1, predose, n=6,10.000 ± 0.00000.000 ± NA
IL-4, Session 1, Day 1, 1 hour, n=6,10.000 ± 0.00000.000 ± NA
IL-4, Session 1, Day 1, 3 hour, n=6,10.000 ± 0.00000.000 ± NA
IL-4, Session 1, Day 1, 6 hour, n=6,10.000 ± 0.00000.000 ± NA
IL-4, Session 1, Day 2, n=6,10.000 ± 0.00000.000 ± NA
IL-4, Session 1, Day 3, predose, n=6,10.000 ± 0.00000.000 ± NA
IL-4, Session 1, Day 3, 1 hour, n=6,00.000 ± 0.0000—
IL-4, Session 1, Day 3, 3 hour, n=6,00.000 ± 0.0000—
IL-4, Session 1, Day 3, 6 hour, n=6,00.000 ± 0.0000—
IL-4, Session 1, Day 4, n=6,00.000 ± 0.0000—
IL-4, Session 1, Day 5, n=6,00.000 ± 0.0000—
IL-4, Session 2, Day -2, n=6,00.000 ± 0.0000—
IL-4, Session 2, Day 1, predose, n=6,00.000 ± 0.0000—
IL-4, Session 2, Day 1, 1 hour, n=6,00.000 ± 0.0000—
IL-4, Session 2, Day 1, 3 hour, n=6,00.000 ± 0.0000—
IL-4, Session 2, Day 1, 6 hour, n=6,00.000 ± 0.0000—
IL-4, Session 2, Day 2, n=6,00.000 ± 0.0000—
IL-4, Session 2, Day 3, predose, n=6,00.000 ± 0.0000—
IL-4, Session 2, Day 3, 1 hour, n=6,00.000 ± 0.0000—
IL-4, Session 2, Day 3, 3 hour, n=6,00.000 ± 0.0000—
IL-4, Session 2, Day 3, 6 hour, n=6,00.000 ± 0.0000—
IL-4, Session 2, Day 4, n=6,00.000 ± 0.0000—
IL-4, Session 2, Day 5, n=6,00.000 ± 0.0000—
IL-4, Session 3, Day -2, n=5,00.000 ± 0.0000—
IL-4, Session 3, Day 1, predose, n=6,00.000 ± 0.0000—
IL-4, Session 3, Day 1, 1 hour, n=6,00.000 ± 0.0000—
IL-4, Session 3, Day 1, 3 hour, n=6,00.000 ± 0.0000—
IL-4, Session 3, Day 1, 6 hour, n=6,00.000 ± 0.0000—
IL-4, Session 3, Day 2, n=5,00.000 ± 0.0000—
IL-4, Session 3, Day 3, predose, n=6,00.000 ± 0.0000—
IL-4, Session 3, Day 3, 1 hour, n=6,00.000 ± 0.0000—
IL-4, Session 3, Day 3, 3 hour, n=6,00.000 ± 0.0000—
IL-4, Session 3, Day 3, 6 hour, n=6,00.000 ± 0.0000—
IL-4, Session 3, Day 4, n=6,00.000 ± 0.0000—
IL-4, Session 3, Day 5, n=6,00.000 ± 0.0000—
IL-4, Session 4, Day -2, n=5,00.000 ± 0.0000—
IL-4, Session 4, Day 1, predose, n=5,00.000 ± 0.0000—
IL-4, Session 4, Day 1, 1 hour, n=5,00.000 ± 0.0000—
IL-4, Session 4, Day 1, 3 hour, n=5,00.000 ± 0.0000—
IL-4, Session 4, Day 1, 6 hour, n=5,00.000 ± 0.0000—
IL-4, Session 4, Day 2, n=5,00.000 ± 0.0000—
IL-4, Session 4, Day 3, predose, n=5,00.000 ± 0.0000—
IL-4, Session 4, Day 3, 1 hour, n=5,00.000 ± 0.0000—
IL-4, Session 4, Day 3, 3 hour, n=5,00.000 ± 0.0000—
IL-4, Session 4, Day 3, 6 hour, n=5,00.000 ± 0.0000—
IL-4, Session 4, Day 4, n=5,00.000 ± 0.0000—
IL-4, Session 4, Day 5, n=4,00.000 ± 0.0000—
IL-4, Session 5, Day -2, n=4,00.000 ± 0.0000—
IL-4, Session 5, Day 1, predose, n=4,00.000 ± 0.0000—
IL-4, Session 5, Day 1, 1 hour, n=4,00.000 ± 0.0000—
IL-4, Session 5, Day 1, 3 hour, n=4,00.000 ± 0.0000—
IL-4, Session 5, Day 1, 6 hour, n=4,00.000 ± 0.0000—
IL-4, Session 5, Day 2, n=4,00.000 ± 0.0000—
IL-4, Session 5, Day 3, predose, n=4,00.000 ± 0.0000—
IL-4, Session 5, Day 3, 1 hour, n=4,00.000 ± 0.0000—
IL-4, Session 5, Day 3, 3 hour, n=4,00.000 ± 0.0000—
IL-4, Session 5, Day 3, 6 hour, n=4,00.000 ± 0.0000—
IL-4, Session 5, Day 4, n=4,00.000 ± 0.0000—
IL-4, Session 5, Day 5, n=4,00.000 ± 0.0000—
IL-4, Session 6, Day -2, n=4,00.000 ± 0.0000—
IL-4, Session 6, Day 1, predose, n=4,00.000 ± 0.0000—
IL-4, Session 6, Day 1, 1 hour, n=4,00.000 ± 0.0000—
IL-4, Session 6, Day 1, 3 hour, n=4,00.000 ± 0.0000—
IL-4, Session 6, Day 1, 6 hour, n=4,00.000 ± 0.0000—
IL-4, Session 6, Day 2, n=4,00.000 ± 0.0000—
IL-4, Session 6, Day 3, predose, n=4,00.000 ± 0.0000—
IL-4, Session 6, Day 3, 1 hour, n=4,00.000 ± 0.0000—
IL-4, Session 6, Day 3, 3 hour, n=4,00.000 ± 0.0000—
IL-4, Session 6, Day 3, 6 hour, n=4,00.000 ± 0.0000—
IL-4, Session 6, Day 4, n=4,00.000 ± 0.0000—
IL-4, Session 6, Day 5, n=4,00.000 ± 0.0000—
IL-8, Session 1, Day 1, predose, n=6,14.377 ± 5.88811.140 ± NA
IL-8, Session 1, Day 1, 1 hour, n=6,14.887 ± 12.04360.450 ± NA
IL-8, Session 1, Day 1, 3 hour, n=6,11.097 ± 6.78340.480 ± NA
IL-8, Session 1, Day 1, 6 hour, n=6,14.400 ± 9.50008.350 ± NA
IL-8, Session 1, Day 2, n=6,110.977 ± 25.460712.720 ± NA
IL-8, Session 1, Day 3, predose, n=6,16.830 ± 10.63099.350 ± NA
IL-8, Session 1, Day 3, 1 hour, n=6,03.035 ± 6.9193—
IL-8, Session 1, Day 3, 3 hour, n=6,0-0.788 ± 4.9840—
IL-8, Session 1, Day 3, 6 hour, n=6,0-0.490 ± 7.3654—
IL-8, Session 1, Day 4, n=6,0-0.542 ± 5.0480—
IL-8, Session 1, Day 5, n=6,01.198 ± 3.0063—
IL-8, Session 2, Day -2, n=6,07.848 ± 12.9271—
IL-8, Session 2, Day 1, predose, n=6,04.920 ± 8.3853—
IL-8, Session 2, Day 1, 1 hour, n=6,01.592 ± 6.9965—
IL-8, Session 2, Day 1, 3 hour, n=6,00.275 ± 7.2669—
IL-8, Session 2, Day 1, 6 hour, n=6,01.243 ± 6.1976—
IL-8, Session 2, Day 2, n=6,05.468 ± 7.5652—
IL-8, Session 2, Day 3, predose, n=6,08.322 ± 5.0082—
IL-8, Session 2, Day 3, 1 hour, n=6,06.432 ± 10.6402—
IL-8, Session 2, Day 3, 3 hour, n=6,0-1.107 ± 5.8160—
IL-8, Session 2, Day 3, 6 hour, n=6,0-0.870 ± 4.6278—
IL-8, Session 2, Day 4, n=6,01.667 ± 5.5170—
IL-8, Session 2, Day 5, n=6,02.853 ± 5.4769—
IL-8, Session 3, Day -2, n=5,012.742 ± 7.8571—
IL-8, Session 3, Day 1, predose, n=6,07.635 ± 6.3602—
IL-8, Session 3, Day 1, 1 hour, n=6,03.848 ± 5.5264—
IL-8, Session 3, Day 1, 3 hour, n=6,0-0.517 ± 5.6983—
IL-8, Session 3, Day 1, 6 hour, n=6,00.933 ± 8.0166—
IL-8, Session 3, Day 2, n=5,03.024 ± 5.5819—
IL-8, Session 3, Day 3, predose, n=6,014.440 ± 13.4971—
IL-8, Session 3, Day 3, 1 hour, n=6,04.887 ± 5.2130—
IL-8, Session 3, Day 3, 3 hour, n=6,00.088 ± 4.3970—
IL-8, Session 3, Day 3, 6 hour, n=6,02.450 ± 6.2029—
IL-8, Session 3, Day 4, n=6,03.680 ± 4.5662—
IL-8, Session 3, Day 5, n=6,07.783 ± 3.9382—
IL-8, Session 4, Day -2, n=5,015.686 ± 10.4436—
IL-8, Session 4, Day 1, predose, n=5,09.910 ± 11.2178—
IL-8, Session 4, Day 1, 1 hour, n=5,010.088 ± 13.7154—
IL-8, Session 4, Day 1, 3 hour, n=5,05.242 ± 11.1547—
IL-8, Session 4, Day 1, 6 hour, n=5,06.992 ± 12.0857—
IL-8, Session 4, Day 2, n=5,04.282 ± 8.9442—
IL-8, Session 4, Day 3, predose, n=5,015.072 ± 11.8360—
IL-8, Session 4, Day 3, 1 hour, n=5,010.536 ± 8.8924—
IL-8, Session 4, Day 3, 3 hour, n=5,01.474 ± 3.3523—
IL-8, Session 4, Day 3, 6 hour, n=5,01.208 ± 3.6252—
IL-8, Session 4, Day 4, n=5,07.118 ± 14.6164—
IL-8, Session 4, Day 5, n=4,0-1.795 ± 4.8526—
IL-8, Session 5, Day -2, n=4,021.055 ± 14.5161—
IL-8, Session 5, Day 1, predose, n=4,018.213 ± 16.0292—
IL-8, Session 5, Day 1, 1 hour, n=4,017.667 ± 15.2020—
IL-8, Session 5, Day 1, 3 hour, n=4,012.463 ± 16.7548—
IL-8, Session 5, Day 1, 6 hour, n=4,05.617 ± 8.7263—
IL-8, Session 5, Day 2, n=4,05.463 ± 9.5943—
IL-8, Session 5, Day 3, predose, n=4,016.915 ± 13.4207—
IL-8, Session 5, Day 3, 1 hour, n=4,09.240 ± 11.0353—
IL-8, Session 5, Day 3, 3 hour, n=4,05.902 ± 9.1992—
IL-8, Session 5, Day 3, 6 hour, n=4,05.335 ± 7.4134—
IL-8, Session 5, Day 4, n=4,07.610 ± 12.4139—
IL-8, Session 5, Day 5, n=4,07.330 ± 14.2059—
IL-8, Session 6, Day -2, n=4,012.908 ± 11.2540—
IL-8, Session 6, Day 1, predose, n=4,017.575 ± 14.9713—
IL-8, Session 6, Day 1, 1 hour, n=4,018.718 ± 14.2024—
IL-8, Session 6, Day 1, 3 hour, n=4,013.823 ± 18.3486—
IL-8, Session 6, Day 1, 6 hour, n=4,012.923 ± 15.0125—
IL-8, Session 6, Day 2, n=4,013.338 ± 15.7070—
IL-8, Session 6, Day 3, predose, n=4,025.338 ± 17.9965—
IL-8, Session 6, Day 3, 1 hour, n=4,011.733 ± 12.1142—
IL-8, Session 6, Day 3, 3 hour, n=4,06.853 ± 7.9858—
IL-8, Session 6, Day 3, 6 hour, n=4,07.220 ± 9.8022—
IL-8, Session 6, Day 4, n=4,013.500 ± 13.0942—
IL-8, Session 6, Day 5, n=4,014.130 ± 9.1046—
SecondaryChange From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time

Blood samples were collected for assessment of Fluid Phase Complement Markers which included complement 3 (C3). Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Time frame:
Baseline (Day -1) and Session 1 to 6: Day 1 (predose, 2,4,8 hours), Day 2, Day 3 (predose, 2,4,8 hours), Day 5, Day 6
Reported as:
Mean · Grams per Liter (g/L)
Change From Baseline in Fluid Phase Complement Marker-Complement 3 (C3) Over Time
Grams per Liter (g/L)Group 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
C3, Session 1, Day 1, predose, n=6,1-0.032 ± 0.1444-0.150 ± NA
C3, Session 1, Day 1, 2 hour, n=6,1-0.008 ± 0.1105-0.230 ± NA
C3, Session 1, Day 1, 4 hour, n=6,10.030 ± 0.0566-0.100 ± NA
C3, Session 1, Day 1, 8 hour, n=6,10.068 ± 0.2073-0.160 ± NA
C3, Session 1, Day 2, n=6,1-0.125 ± 0.1033-0.180 ± NA
C3, Session 1, Day 3, predose, n=6,1-0.198 ± 0.1607-0.200 ± NA
C3, Session 1, Day 3, 2 hour, n=6,0-0.188 ± 0.1572—
C3, Session 1, Day 3, 4 hour, n=6,0-0.222 ± 0.1288—
C3, Session 1, Day 3, 8 hour, n=6,0-0.155 ± 0.1590—
C3, Session 1, Day 5, n=6,0-0.280 ± 0.1646—
C3, Session 1, Day 6, n=6,0-0.338 ± 0.1969—
C3, Session 2, Day 1, predose, n=6,0-0.067 ± 0.1999—
C3, Session 2, Day 1, 2 hour, n=6,0-0.103 ± 0.1629—
C3, Session 2, Day 1, 4 hour, n=6,0-0.075 ± 0.2017—
C3, Session 2, Day 1, 8 hour, n=6,0-0.130 ± 0.1585—
C3, Session 2, Day 2, n=6,0-0.153 ± 0.1485—
C3, Session 2, Day 3, predose, n=6,0-0.263 ± 0.1385—
C3, Session 2, Day 3, 2 hour, n=6,0-0.242 ± 0.1694—
C3, Session 2, Day 3, 4 hour, n=6,0-0.243 ± 0.1994—
C3, Session 2, Day 3, 8 hour, n=6,0-0.235 ± 0.1685—
C3, Session 2, Day 5, n=6,0-0.280 ± 0.1716—
C3, Session 2, Day 6, n=6,0-0.327 ± 0.2298—
C3, Session 3, Day 1, predose, n=6,0-0.053 ± 0.1928—
C3, Session 3, Day 1, 2 hour, n=6,0-0.078 ± 0.2279—
C3, Session 3, Day 1, 4 hour, n=6,0-0.058 ± 0.2299—
C3, Session 3, Day 1, 8 hour, n=6,0-0.057 ± 0.1999—
C3, Session 3, Day 2, n=5,0-0.084 ± 0.2792—
C3, Session 3, Day 3, predose, n=6,0-0.215 ± 0.1576—
C3, Session 3, Day 3, 2 hour, n=6,0-0.232 ± 0.1699—
C3, Session 3, Day 3, 4 hour, n=6,0-0.200 ± 0.1808—
C3, Session 3, Day 3, 8 hour, n=6,0-0.190 ± 0.2287—
C3, Session 3, Day 5, n=6,0-0.290 ± 0.1719—
C3, Session 3, Day 6, n=6,0-0.308 ± 0.2077—
C3, Session 4, Day 1, predose, n=5,0-0.094 ± 0.2271—
C3, Session 4, Day 1, 2 hour, n=5,0-0.088 ± 0.1993—
C3, Session 4, Day 1, 4 hour, n=4,0-0.005 ± 0.1392—
C3, Session 4, Day 1, 8 hour, n=5,0-0.124 ± 0.1747—
C3, Session 4, Day 2, n=5,0-0.144 ± 0.1641—
C3, Session 4, Day 3, predose, n=5,0-0.214 ± 0.2454—
C3, Session 4, Day 3, 2 hour, n=5,0-0.204 ± 0.2306—
C3, Session 4, Day 3, 4 hour, n=5,0-0.190 ± 0.2088—
C3, Session 4, Day 3, 8 hour, n=5,0-0.188 ± 0.2305—
C3, Session 4, Day 5, n=5,0-0.270 ± 0.1996—
C3, Session 4, Day 6, n=5,0-0.302 ± 0.2251—
C3, Session 5, Day 1, predose, n=4,0-0.173 ± 0.1863—
C3, Session 5, Day 1, 2 hour, n=4,0-0.147 ± 0.2326—
C3, Session 5, Day 1, 4 hour, n=4,0-0.125 ± 0.1741—
C3, Session 5, Day 1, 8 hour, n=4,0-0.150 ± 0.1881—
C3, Session 5, Day 2, n=4,0-0.178 ± 0.2340—
C3, Session 5, Day 3, predose, n=4,0-0.248 ± 0.1919—
C3, Session 5, Day 3, 2 hour, n=4,0-0.235 ± 0.1964—
C3, Session 5, Day 3, 4 hour, n=4,0-0.280 ± 0.2045—
C3, Session 5, Day 3, 8 hour, n=4,0-0.235 ± 0.2301—
C3, Session 5, Day 5, n=4,0-0.258 ± 0.2035—
C3, Session 5, Day 6, n=4,0-0.288 ± 0.1941—
C3, Session 6, Day 1, predose, n=4,0-0.152 ± 0.2144—
C3, Session 6, Day 1, 2 hour, n=4,0-0.145 ± 0.1877—
C3, Session 6, Day 1, 4 hour, n=4,0-0.145 ± 0.2528—
C3, Session 6, Day 1, 8 hour, n=4,0-0.135 ± 0.2626—
C3, Session 6, Day 2, n=4,0-0.203 ± 0.2090—
C3, Session 6, Day 3, predose, n=4,0-0.215 ± 0.2319—
C3, Session 6, Day 3, 2 hour, n=4,0-0.273 ± 0.2179—
C3, Session 6, Day 3, 4 hour, n=4,0-0.235 ± 0.2243—
C3, Session 6, Day 3, 8 hour, n=4,0-0.238 ± 0.2421—
C3, Session 6, Day 5, n=4,0-0.288 ± 0.2269—
C3, Session 6, Day 6, n=4,0-0.315 ± 0.2225—
SecondaryChange From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time

Blood samples were collected for assessment of Fluid Phase Complement Markers which included complement 4 (C4). Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Time frame:
Baseline (Day -1) and Day 2, Day 5, Day 6
Reported as:
Mean · Grams per Liter (g/L)
Change From Baseline in Fluid Phase Complement Marker-Complement 4 (C4) Over Time
Grams per Liter (g/L)Group 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
C4, Session 1, Day 2, n=6,1-0.015 ± 0.03730.000 ± NA
C4, Session 1, Day 5, n=6,0-0.013 ± 0.0393—
C4, Session 1, Day 6, n=6,0-0.017 ± 0.0403—
C4, Session 2, Day 2, n=6,0-0.027 ± 0.0423—
C4, Session 2, Day 5, n=6,0-0.023 ± 0.0505—
C4, Session 2, Day 6, n=6,0-0.030 ± 0.0540—
C4, Session 3, Day 2, n=5,0-0.010 ± 0.0543—
C4, Session 3, Day 5, n=6,0-0.042 ± 0.0449—
C4, Session 3, Day 6, n=6,0-0.042 ± 0.0542—
C4, Session 4, Day 2, n=5,0-0.022 ± 0.0531—
C4, Session 4, Day 5, n=5,0-0.036 ± 0.0677—
C4, Session 4, Day 6, n=5,0-0.042 ± 0.0507—
C4, Session 5, Day 2, n=4,0-0.028 ± 0.0574—
C4, Session 5, Day 5, n=4,0-0.033 ± 0.0574—
C4, Session 5, Day 6, n=4,0-0.025 ± 0.0545—
C4, Session 6, Day 2, n=4,0-0.043 ± 0.0544—
C4, Session 6, Day 5, n=4,0-0.050 ± 0.0678—
C4, Session 6, Day 6, n=4,0-0.045 ± 0.0666—
SecondaryChange From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time

Blood samples were collected for assessment of Fluid Phase Complement Markers which included total complement (CH50). Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Time frame:
Baseline (Day -1) and Session 1 to 6: Day 1 (predose, 2,4,8 hours), Day 2, Day 3 (predose, 2,4,8 hours), Day 5, Day 6
Reported as:
Mean · Units per milliliter
Change From Baseline in Fluid Phase Complement Marker-Total Complement (CH50) Over Time
Units per milliliterGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
CH50, Session 1, Day 1, predose, n=6,1-0.7 ± 1.370.0 ± NA
CH50, Session 1, Day 1, 2 hour, n=6,1-0.8 ± 1.330.0 ± NA
CH50, Session 1, Day 1, 4 hour, n=6,10.2 ± 0.410.0 ± NA
CH50, Session 1, Day 1, 8 hour, n=6,1-0.8 ± 1.600.0 ± NA
CH50, Session 1, Day 2, n=6,1-2.7 ± 3.200.0 ± NA
CH50, Session 1, Day 3, predose, n=6,1-3.3 ± 4.460.0 ± NA
CH50, Session 1, Day 3, 2 hour, n=6,0-3.3 ± 4.37—
CH50, Session 1, Day 3, 4 hour, n=6,0-2.5 ± 3.78—
CH50, Session 1, Day 3, 8 hour, n=6,0-2.2 ± 3.25—
CH50, Session 1, Day 5, n=6,0-4.7 ± 5.01—
CH50, Session 1, Day 6, n=6,0-7.3 ± 6.19—
CH50, Session 2, Day 1, predose, n=6,0-1.7 ± 3.67—
CH50, Session 2, Day 1, 2 hour, n=6,0-2.3 ± 4.84—
CH50, Session 2, Day 1, 4 hour, n=6,0-2.3 ± 4.63—
CH50, Session 2, Day 1, 8 hour, n=6,0-3.5 ± 7.84—
CH50, Session 2, Day 2, n=6,0-4.3 ± 6.02—
CH50, Session 2, Day 3, predose, n=6,0-4.5 ± 6.16—
CH50, Session 2, Day 3, 2 hour, n=6,0-4.0 ± 5.55—
CH50, Session 2, Day 3, 4 hour, n=6,0-3.8 ± 6.31—
CH50, Session 2, Day 3, 8 hour, n=6,0-3.8 ± 3.92—
CH50, Session 2, Day 5, n=6,0-5.2 ± 6.31—
CH50, Session 2, Day 6, n=6,0-8.5 ± 9.61—
CH50, Session 3, Day 1, predose, n=6,0-4.5 ± 7.94—
CH50, Session 3, Day 1, 2 hour, n=6,0-4.2 ± 7.44—
CH50, Session 3, Day 1, 4 hour, n=6,0-4.5 ± 7.79—
CH50, Session 3, Day 1, 8 hour, n=6,0-4.8 ± 8.35—
CH50, Session 3, Day 2, n=5,0-3.6 ± 8.68—
CH50, Session 3, Day 3, predose, n=6,0-5.2 ± 8.86—
CH50, Session 3, Day 3, 2 hour, n=6,0-5.2 ± 8.86—
CH50, Session 3, Day 3, 4 hour, n=6,0-5.3 ± 8.57—
CH50, Session 3, Day 3, 8 hour, n=6,0-6.8 ± 10.05—
CH50, Session 3, Day 5, n=6,0-7.0 ± 10.28—
CH50, Session 3, Day 6, n=6,0-8.2 ± 11.02—
CH50, Session 4, Day 1, predose, n=5,0-3.0 ± 5.20—
CH50, Session 4, Day 1, 2 hour, n=5,0-2.0 ± 3.94—
CH50, Session 4, Day 1, 4 hour, n=5,0-1.6 ± 4.77—
CH50, Session 4, Day 1, 8 hour, n=5,0-1.6 ± 3.21—
CH50, Session 4, Day 2, n=5,0-1.6 ± 3.13—
CH50, Session 4, Day 3, predose, n=5,0-5.0 ± 6.08—
CH50, Session 4, Day 3, 2 hour, n=5,0-3.2 ± 4.09—
CH50, Session 4, Day 3, 4 hour, n=5,0-3.0 ± 6.40—
CH50, Session 4, Day 3, 8 hour, n=5,0-4.0 ± 6.04—
CH50, Session 4, Day 5, n=5,0-5.6 ± 7.70—
CH50, Session 4, Day 6, n=5,0-6.6 ± 7.83—
CH50, Session 5, Day 1, predose, n=4,0-3.8 ± 5.91—
CH50, Session 5, Day 1, 2 hour, n=4,0-3.0 ± 5.72—
CH50, Session 5, Day 1, 4 hour, n=4,0-2.8 ± 6.29—
CH50, Session 5, Day 1, 8 hour, n=4,0-3.0 ± 5.29—
CH50, Session 5, Day 2, n=4,0-3.5 ± 5.32—
CH50, Session 5, Day 3, predose, n=4,0-5.0 ± 5.77—
CH50, Session 5, Day 3, 2 hour, n=4,0-4.8 ± 6.80—
CH50, Session 5, Day 3, 4 hour, n=4,0-4.8 ± 6.70—
CH50, Session 5, Day 3, 8 hour, n=4,0-4.8 ± 6.80—
CH50, Session 5, Day 5, n=4,0-5.5 ± 7.72—
CH50, Session 5, Day 6, n=4,0-5.3 ± 8.54—
CH50, Session 6, Day 1, predose, n=4,0-2.3 ± 4.03—
CH50, Session 6, Day 1, 2 hour, n=4,0-2.8 ± 6.90—
CH50, Session 6, Day 1, 4 hour, n=4,0-3.3 ± 7.27—
CH50, Session 6, Day 1, 8 hour, n=4,0-3.5 ± 6.66—
CH50, Session 6, Day 2, n=4,0-4.3 ± 6.13—
CH50, Session 6, Day 3, predose, n=4,0-5.0 ± 8.52—
CH50, Session 6, Day 3, 2 hour, n=4,0-4.8 ± 8.54—
CH50, Session 6, Day 3, 4 hour, n=4,0-4.3 ± 8.66—
CH50, Session 6, Day 3, 8 hour, n=4,0-5.0 ± 8.52—
CH50, Session 6, Day 5, n=4,0-5.3 ± 9.00—
CH50, Session 6, Day 6, n=4,0-5.5 ± 9.47—
SecondaryChange From Baseline in Inflammatory Biomarkers Over Time

Blood samples were collected for assessment of inflammatory biomarkers which included C-Reactive protein (CRP), high-sensitivity C-reactive protein (hsCRP), serum amyloid A protein (SAA). Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Time frame:
Baseline (Day -1) and Session 1 to 6: Day 1 (predose, 2,4,8 hours), Day 2, Day 3 (predose, 2,4,8 hours), Day 5, Day 6
Reported as:
Mean · Milligrams per Liter (mg/L)
Change From Baseline in Inflammatory Biomarkers Over Time
Milligrams per Liter (mg/L)Group 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
CRP, Session 1, Day 1, predose, n=5,1-0.12 ± 0.572-4.60 ± NA
CRP, Session 1, Day 1, 2 hour, n=5,1-0.26 ± 0.573-4.80 ± NA
CRP, Session 1, Day 1, 4 hour, n=4,1-0.28 ± 0.486-4.70 ± NA
CRP, Session 1, Day 1, 8 hour, n=5,1-0.18 ± 0.634-4.60 ± NA
CRP, Session 1, Day 2, n=5,10.64 ± 1.70144.70 ± NA
CRP, Session 1, Day 3, predose, n=5,114.08 ± 12.511131.20 ± NA
CRP, Session 1, Day 3, 2 hour, n=5,014.52 ± 13.128—
CRP, Session 1, Day 3, 4 hour, n=5,015.30 ± 13.119—
CRP, Session 1, Day 3, 8 hour, n=5,017.64 ± 14.527—
CRP, Session 1, Day 5, n=5,017.20 ± 14.772—
CRP, Session 1, Day 6, n=5,019.52 ± 15.665—
CRP, Session 2, Day 1, predose, n=5,02.24 ± 2.864—
CRP, Session 2, Day 1, 2 hour, n=5,02.12 ± 2.613—
CRP, Session 2, Day 1, 4 hour, n=5,02.18 ± 2.710—
CRP, Session 2, Day 1, 8 hour, n=5,02.18 ± 2.658—
CRP, Session 2, Day 2, n=4,02.00 ± 2.624—
CRP, Session 2, Day 3, predose, n=5,027.42 ± 26.283—
CRP, Session 2, Day 3, 2 hour, n=5,029.46 ± 27.415—
CRP, Session 2, Day 3, 4 hour, n=5,030.90 ± 27.961—
CRP, Session 2, Day 3, 8 hour, n=5,031.76 ± 27.897—
CRP, Session 2, Day 5, n=4,028.33 ± 22.386—
CRP, Session 2, Day 6, n=5,027.04 ± 18.632—
CRP, Session 3, Day 1, predose, n=4,01.93 ± 2.343—
CRP, Session 3, Day 1, 2 hour, n=4,02.05 ± 2.626—
CRP, Session 3, Day 1, 4 hour, n=4,02.15 ± 2.891—
CRP, Session 3, Day 1, 8 hour, n=4,02.15 ± 2.760—
CRP, Session 3, Day 2, n=4,01.75 ± 2.161—
CRP, Session 3, Day 3, predose, n=4,018.13 ± 15.476—
CRP, Session 3, Day 3, 2 hour, n=4,019.40 ± 16.403—
CRP, Session 3, Day 3, 4 hour, n=4,021.20 ± 17.827—
CRP, Session 3, Day 3, 8 hour, n=4,022.63 ± 18.466—
CRP, Session 3, Day 5, n=5,019.00 ± 15.625—
CRP, Session 3, Day 6, n=4,024.10 ± 16.785—
CRP, Session 4, Day 1, predose, n=4,02.33 ± 4.487—
CRP, Session 4, Day 1, 2 hour, n=4,02.53 ± 4.762—
CRP, Session 4, Day 1, 4 hour, n=4,02.45 ± 4.669—
CRP, Session 4, Day 1, 8 hour, n=4,02.40 ± 4.455—
CRP, Session 4, Day 2, n=4,02.23 ± 3.963—
CRP, Session 4, Day 3, predose, n=4,012.45 ± 13.533—
CRP, Session 4, Day 3, 2 hour, n=4,014.75 ± 16.539—
CRP, Session 4, Day 3, 4 hour, n=4,016.75 ± 19.129—
CRP, Session 4, Day 3, 8 hour, n=4,017.30 ± 17.830—
CRP, Session 4, Day 5, n=4,018.43 ± 9.959—
CRP, Session 4, Day 6, n=4,019.98 ± 11.277—
CRP, Session 5, Day 1, predose, n=3,02.23 ± 3.439—
CRP, Session 5, Day 1, 2 hour, n=3,02.13 ± 3.350—
CRP, Session 5, Day 1, 4 hour, n=3,01.97 ± 3.147—
CRP, Session 5, Day 1, 8 hour, n=3,02.10 ± 3.378—
CRP, Session 5, Day 2, n=3,01.37 ± 2.811—
CRP, Session 5, Day 3, predose, n=3,08.33 ± 11.517—
CRP, Session 5, Day 3, 2 hour, n=3,09.87 ± 12.881—
CRP, Session 5, Day 3, 4 hour, n=3,010.47 ± 12.874—
CRP, Session 5, Day 3, 8 hour, n=3,012.90 ± 14.944—
CRP, Session 5, Day 5, n=2,034.30 ± 40.588—
CRP, Session 5, Day 6, n=2,035.20 ± 34.931—
CRP, Session 6, Day 1, predose, n=3,04.00 ± 3.851—
CRP, Session 6, Day 1, 2 hour, n=3,03.63 ± 3.711—
CRP, Session 6, Day 1, 4 hour, n=3,03.70 ± 3.835—
CRP, Session 6, Day 1, 8 hour, n=3,03.70 ± 3.874—
CRP, Session 6, Day 2, n=3,02.63 ± 2.914—
CRP, Session 6, Day 3, predose, n=3,09.17 ± 8.879—
CRP, Session 6, Day 3, 2 hour, n=3,011.10 ± 10.887—
CRP, Session 6, Day 3, 4 hour, n=3,012.70 ± 11.555—
CRP, Session 6, Day 3, 8 hour, n=3,014.67 ± 12.580—
CRP, Session 6, Day 5, n=3,014.10 ± 7.146—
CRP, Session 6, Day 6, n=3,017.33 ± 7.844—
hsCRP, Session 1, Day 1, predose, n=5,1-0.08 ± 0.356-3.60 ± NA
hsCRP, Session 1, Day 1, 2 hour, n=5,1-0.08 ± 0.327-3.70 ± NA
hsCRP, Session 1, Day 1, 4 hour, n=4,1-0.20 ± 0.271-3.70 ± NA
hsCRP, Session 1, Day 1, 8 hour, n=5,1-0.10 ± 0.406-3.60 ± NA
hsCRP, Session 1, Day 2, n=5,10.56 ± 1.28641.40 ± NA
hsCRP, Session 1, Day 3, predose, n=5,114.54 ± 13.149135.20 ± NA
hsCRP, Session 1, Day 3, 2 hour, n=5,015.14 ± 13.363—
hsCRP, Session 1, Day 3, 4 hour, n=5,015.84 ± 13.607—
hsCRP, Session 1, Day 3, 8 hour, n=5,017.10 ± 14.294—
hsCRP, Session 1, Day 5, n=5,016.70 ± 14.332—
hsCRP, Session 1, Day 6, n=5,018.60 ± 14.778—
hsCRP, Session 2, Day 1, predose, n=5,01.88 ± 2.539—
hsCRP, Session 2, Day 1, 2 hour, n=5,01.78 ± 2.351—
hsCRP, Session 2, Day 1, 4 hour, n=5,01.90 ± 2.478—
hsCRP, Session 2, Day 1, 8 hour, n=5,01.78 ± 2.179—
hsCRP, Session 2, Day 2, n=4,01.75 ± 2.266—
hsCRP, Session 2, Day 3, predose, n=5,026.76 ± 26.122—
hsCRP, Session 2, Day 3, 2 hour, n=5,029.28 ± 27.373—
hsCRP, Session 2, Day 3, 4 hour, n=5,030.36 ± 27.018—
hsCRP, Session 2, Day 3, 8 hour, n=5,031.10 ± 26.885—
hsCRP, Session 2, Day 5, n=4,028.13 ± 21.919—
hsCRP, Session 2, Day 6, n=5,027.20 ± 18.468—
hsCRP, Session 3, Day 1, predose, n=4,01.60 ± 2.017—
hsCRP, Session 3, Day 1, 2 hour, n=4,01.63 ± 2.175—
hsCRP, Session 3, Day 1, 4 hour, n=4,01.70 ± 2.403—
hsCRP, Session 3, Day 1, 8 hour, n=4,01.65 ± 2.161—
hsCRP, Session 3, Day 2, n=4,01.25 ± 1.754—
hsCRP, Session 3, Day 3, predose, n=4,017.88 ± 15.954—
hsCRP, Session 3, Day 3, 2 hour, n=4,019.23 ± 16.675—
hsCRP, Session 3, Day 3, 4 hour, n=4,020.58 ± 17.733—
hsCRP, Session 3, Day 3, 8 hour, n=4,022.10 ± 18.149—
hsCRP, Session 3, Day 5, n=4,022.45 ± 15.042—
hsCRP, Session 3, Day 6, n=4,023.73 ± 16.141—
hsCRP, Session 4, Day 1, predose, n=4,02.28 ± 4.043—
hsCRP, Session 4, Day 1, 2 hour, n=4,02.53 ± 4.610—
hsCRP, Session 4, Day 1, 4 hour, n=4,02.53 ± 4.479—
hsCRP, Session 4, Day 1, 8 hour, n=4,02.58 ± 4.528—
hsCRP, Session 4, Day 2, n=4,02.20 ± 3.558—
hsCRP, Session 4, Day 3, predose, n=4,012.33 ± 13.881—
hsCRP, Session 4, Day 3, 2 hour, n=4,014.40 ± 16.324—
hsCRP, Session 4, Day 3, 4 hour, n=4,016.00 ± 18.240—
hsCRP, Session 4, Day 3, 8 hour, n=4,017.08 ± 17.972—
hsCRP, Session 4, Day 5, n=4,019.60 ± 10.903—
hsCRP, Session 4, Day 6, n=4,020.73 ± 11.391—
hsCRP, Session 5, Day 1, predose, n=3,02.03 ± 3.349—
hsCRP, Session 5, Day 1, 2 hour, n=3,01.97 ± 3.320—
hsCRP, Session 5, Day 1, 4 hour, n=3,01.83 ± 3.175—
hsCRP, Session 5, Day 1, 8 hour, n=3,01.87 ± 3.323—
hsCRP, Session 5, Day 2, n=3,01.23 ± 2.574—
hsCRP, Session 5, Day 3, predose, n=3,09.10 ± 13.182—
hsCRP, Session 5, Day 3, 2 hour, n=3,010.43 ± 14.629—
hsCRP, Session 5, Day 3, 4 hour, n=3,011.17 ± 14.865—
hsCRP, Session 5, Day 3, 8 hour, n=3,012.67 ± 15.557—
hsCRP, Session 5, Day 5, n=2,033.95 ± 40.941—
hsCRP, Session 5, Day 6, n=2,034.80 ± 34.083—
hsCRP, Session 6, Day 1, predose, n=3,03.77 ± 3.853—
hsCRP, Session 6, Day 1, 2 hour, n=3,03.37 ± 3.523—
hsCRP, Session 6, Day 1, 4 hour, n=3,03.50 ± 3.799—
hsCRP, Session 6, Day 1, 8 hour, n=3,03.27 ± 3.584—
hsCRP, Session 6, Day 2, n=3,02.33 ± 2.775—
hsCRP, Session 6, Day 3, predose, n=3,08.97 ± 9.752—
hsCRP, Session 6, Day 3, 2 hour, n=3,010.57 ± 11.075—
hsCRP, Session 6, Day 3, 4 hour, n=3,012.60 ± 12.322—
hsCRP, Session 6, Day 3, 8 hour, n=3,015.33 ± 14.276—
hsCRP, Session 6, Day 5, n=3,014.43 ± 7.801—
hsCRP, Session 6, Day 6, n=3,018.63 ± 8.607—
SAA, Session 1, Day 1, predose, n=5,10.2164 ± 1.55486-22.3723 ± NA
SAA, Session 1, Day 1, 2 hour, n=5,10.1738 ± 1.13909-22.4187 ± NA
SAA, Session 1, Day 1, 4 hour, n=5,10.3902 ± 1.56253-21.7463 ± NA
SAA, Session 1, Day 1, 8 hour, n=5,10.2695 ± 1.57992-14.8767 ± NA
SAA, Session 1, Day 2, n=5,12.9247 ± 3.47577322.2895 ± NA
SAA, Session 1, Day 3, predose, n=5,150.7137 ± 55.029691437.7667 ± NA
SAA, Session 1, Day 3, 2 hour, n=5,054.8466 ± 59.36005—
SAA, Session 1, Day 3, 4 hour, n=5,054.9329 ± 55.92645—
SAA, Session 1, Day 3, 8 hour, n=5,068.4699 ± 75.51138—
SAA, Session 1, Day 5, n=5,054.6741 ± 69.66316—
SAA, Session 1, Day 6, n=5,055.2882 ± 63.77870—
SAA, Session 2, Day 1, predose, n=5,01.0277 ± 1.64965—
SAA, Session 2, Day 1, 2 hour, n=5,00.9841 ± 2.22042—
SAA, Session 2, Day 1, 4 hour, n=5,01.4543 ± 2.61184—
SAA, Session 2, Day 1, 8 hour, n=5,01.0588 ± 1.52455—
SAA, Session 2, Day 2, n=5,03.7244 ± 1.63856—
SAA, Session 2, Day 3, predose, n=5,0134.4489 ± 160.14208—
SAA, Session 2, Day 3, 2 hour, n=5,0145.2507 ± 171.92591—
SAA, Session 2, Day 3, 4 hour, n=5,0142.5438 ± 174.11156—
SAA, Session 2, Day 3, 8 hour, n=5,0100.8836 ± 184.35963—
SAA, Session 2, Day 5, n=5,076.8593 ± 136.83379—
SAA, Session 2, Day 6, n=5,0101.0688 ± 105.88787—
SAA, Session 3, Day 1, predose, n=4,00.2428 ± 1.13002—
SAA, Session 3, Day 1, 2 hour, n=4,00.1863 ± 1.06333—
SAA, Session 3, Day 1, 4 hour, n=4,00.0475 ± 1.00422—
SAA, Session 3, Day 1, 8 hour, n=5,04.0339 ± 8.62955—
SAA, Session 3, Day 2, n=4,06.4822 ± 11.14119—
SAA, Session 3, Day 3, predose, n=5,054.7393 ± 82.22346—
SAA, Session 3, Day 3, 2 hour, n=5,058.0526 ± 83.12677—
SAA, Session 3, Day 3, 4 hour, n=5,064.1995 ± 93.61736—
SAA, Session 3, Day 3, 8 hour, n=5,066.9605 ± 93.98658—
SAA, Session 3, Day 5, n=5,058.6742 ± 50.93398—
SAA, Session 3, Day 6, n=5,049.4029 ± 46.30012—
SAA, Session 4, Day 1, predose, n=4,0-0.1305 ± 1.86822—
SAA, Session 4, Day 1, 2 hour, n=4,00.0159 ± 1.91086—
SAA, Session 4, Day 1, 4 hour, n=4,0-0.0013 ± 1.84104—
SAA, Session 4, Day 1, 8 hour, n=4,00.1997 ± 1.70496—
SAA, Session 4, Day 2, n=4,01.6015 ± 1.07082—
SAA, Session 4, Day 3, predose, n=4,045.1067 ± 82.67535—
SAA, Session 4, Day 3, 2 hour, n=4,051.0650 ± 94.33211—
SAA, Session 4, Day 3, 4 hour, n=4,055.0009 ± 101.37965—
SAA, Session 4, Day 3, 8 hour, n=4,055.7135 ± 101.39069—
SAA, Session 4, Day 5, n=4,051.2002 ± 54.84780—
SAA, Session 4, Day 6, n=4,041.2457 ± 38.77052—
SAA, Session 5, Day 1, predose, n=3,0-0.1498 ± 1.04561—
SAA, Session 5, Day 1, 2 hour, n=3,0-0.2399 ± 0.89843—
SAA, Session 5, Day 1, 4 hour, n=3,0-0.1906 ± 0.94124—
SAA, Session 5, Day 1, 8 hour, n=3,0-0.1771 ± 0.95814—
SAA, Session 5, Day 2, n=3,00.1380 ± 0.61958—
SAA, Session 5, Day 3, predose, n=3,010.8884 ± 17.72052—
SAA, Session 5, Day 3, 2 hour, n=3,08.6783 ± 11.48176—
SAA, Session 5, Day 3, 4 hour, n=3,09.2527 ± 11.23663—
SAA, Session 5, Day 3, 8 hour, n=3,013.7941 ± 19.39827—
SAA, Session 5, Day 5, n=3,066.2542 ± 107.98594—
SAA, Session 5, Day 6, n=3,073.0823 ± 118.07036—
SAA, Session 6, Day 1, predose, n=3,01.2964 ± 1.75482—
SAA, Session 6, Day 1, 2 hour, n=3,01.0538 ± 1.74392—
SAA, Session 6, Day 1, 4 hour, n=3,01.3139 ± 2.18542—
SAA, Session 6, Day 1, 8 hour, n=3,00.9078 ± 1.72500—
SAA, Session 6, Day 2, n=3,01.2641 ± 0.89837—
SAA, Session 6, Day 3, predose, n=3,07.4697 ± 5.41886—
SAA, Session 6, Day 3, 2 hour, n=3,08.3574 ± 4.40865—
SAA, Session 6, Day 3, 4 hour, n=3,011.0305 ± 8.80978—
SAA, Session 6, Day 3, 8 hour, n=3,014.5333 ± 12.26460—
SAA, Session 6, Day 5, n=3,025.2529 ± 27.55204—
SAA, Session 6, Day 6, n=3,032.6318 ± 41.82856—
SecondaryMaximum Concentration (Cmax) of GSK2398852

Blood samples were collected for evaluation of Pharmacokinetic (PK) parameters including Cmax at indicated time points. Geometric mean and geometric coefficient of variation of Cmax is presented.

Time frame:
Session 1 to 6: Day 1 (Pre-dose, 6, 8, 12 hour), Day 2, Day 3 (Pre-dose and at 6 hour), Day 4, Day 7 and Day 11
Reported as:
Geometric mean · Micrograms per milliliter (ug/mL)
Maximum Concentration (Cmax) of GSK2398852
Micrograms per milliliter (ug/mL)Group 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
Session 1, n=6,186.94 ± 31.5888.64 ± NA
Session 2, n=6,0235.48 ± 25.22—
Session 3, n=6,0222.23 ± 44.40—
Session 4, n=5,0179.82 ± 33.87—
Session 5, n=4,0185.52 ± 34.06—
Session 6, n=4,0228.51 ± 49.73—
SecondaryTime Associated With Cmax (Tmax) of GSK2398852

Blood samples were collected for evaluation of PK parameters including Tmax at indicated time points. Median and full range of Tmax is presented.

Time frame:
Session 1 to 6: Day 1 (Pre-dose, 6, 8, 12 hour), Day 2, Day 3 (Pre-dose and at 6 hour), Day 4, Day 7 and Day 11
Reported as:
Median · Hour
Time Associated With Cmax (Tmax) of GSK2398852
HourGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
Session 1, n=6,154.18 (53.9 to 54.9)6.1 (6.1 to 6.1)
Session 2, n=6,054.07 (53.3 to 54.7)—
Session 3, n=6,054.06 (12.1 to 55.8)—
Session 4, n=5,054.50 (53.9 to 56.1)—
Session 5, n=4,054.28 (6.1 to 56.1)—
Session 6, n=4,054.18 (53.9 to 56.0)—
SecondaryArea Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC 0-t) of GSK2398852

Blood samples were collected for evaluation of PK parameters including AUC 0-t at indicated time points. Geometric mean and geometric coefficient of variation of AUC0-t is presented.

Time frame:
Session 1 to 6: Day 1 (Pre-dose, 6, 8, 12 hour), Day 2, Day 3 (Pre-dose and at 6 hour), Day 4, Day 7 and Day 11
Reported as:
Geometric mean · Hour*micrograms per milliliter (h*ug/mL)
Area Under the Plasma Concentration-time Curve From Time Zero to Time t (AUC 0-t) of GSK2398852
Hour*micrograms per milliliter (h*ug/mL)Group 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
Session 1, n=6,15130.0 ± 46.722148.2 ± NA
Session 2, n=6,014610.1 ± 34.73—
Session 3, n=6,013804.6 ± 50.34—
Session 4, n=5,012970.9 ± 51.52—
Session 5, n=4,015595.3 ± 51.13—
Session 6, n=4,017126.7 ± 43.98—
SecondaryCmax of GSK2315698 for Newly Diagnosed Mayo Stage II/IIIa AL Amyloidosis Participants

Blood samples were planned to be collected for evaluation of PK parameters including Cmax at indicated time points for GSK2315698 for newly diagnosed Mayo stage II/IIIa AL Amyloidosis participants. However, no participant was enrolled in 'Group 3: Newly diagnosed Mayo stage II/IIIa AL participants.'

Time frame:
Day 1: Pre-dose; Day 2 (pre-dose and 2 hours post-dose); Day 3: Pre-dose in each session (each session of 24 days)

No measurements were reported for this outcome.

SecondaryTmax of GSK2315698 for Newly Diagnosed Mayo Stage II/IIIa AL Amyloidosis Participants

Blood samples were planned to be collected for evaluation of PK parameters including Tmax at indicated time points for GSK2315698 for newly diagnosed Mayo stage II/IIIa AL Amyloidosis participants. However, no participant was enrolled in 'Group 3: Newly diagnosed Mayo stage II/IIIa AL participants'.

Time frame:
Day 1: Pre-dose; Day 2: pre-dose and 2 hours post-dose; Day 3: Pre-dose in each session (each session of 24 days)

No measurements were reported for this outcome.

SecondaryAUC 0-t of GSK2315698 for Newly Diagnosed Mayo Stage II/IIIa AL Amyloidosis Participants

Blood samples were planned to be collected for evaluation of PK parameters including AUC0-t at indicated time points for GSK2315698 for newly diagnosed Mayo stage II/IIIa AL Amyloidosis participants. However, no participant was enrolled in 'Group 3: Newly diagnosed Mayo stage II/IIIa AL participants'.

Time frame:
Day 1: Pre-dose; Day 2 (pre-dose and 2 hours post-dose); Day 3: Pre-dose in each session (each session of 24 days)

No measurements were reported for this outcome.

SecondaryChange From Baseline in Global Longitudinal Strain (GLS) by CMR

Global Longitudinal Strain was measured by CMR at indicated time points. GLS included feature tracking and tagging by CMR. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Time frame:
Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-up
Reported as:
Mean · Percentage of myocardial shortening
Change From Baseline in Global Longitudinal Strain (GLS) by CMR
Percentage of myocardial shorteningGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
GLS Tagging, Session 2, Day 24, n=6,00.003 ± 0.2907—
GLS Tagging, Session 3, Day 24, n=6,00.229 ± 0.5836—
GLS Tagging, Session 4, Day 24, n=5,00.392 ± 0.4121—
GLS Tagging, Session 5, Day 24, n=4,00.349 ± 0.9354—
GLS Tagging, 8 Week follow-up, n=6,11.125 ± 1.6448-3.404 ± NA
GLS Tagging, 6 month follow-up, n=2,0-1.014 ± 0.3654—
GLS Feature Tracking, Session 2, Day 24, n=6,01.729 ± 2.3613—
GLS Feature Tracking, Session 3, Day 24, n=6,00.803 ± 2.3712—
GLS Feature Tracking, Session 4, Day 24, n=5,01.326 ± 4.0639—
GLS Feature Tracking, Session 5, Day 24, n=4,01.657 ± 2.1277—
GLS Feature Tracking, 8 Week follow-up, n=6,10.639 ± 1.36783.951 ± NA
GLS Feature Tracking, 6 month follow-up, n=2,01.234 ± 4.6888—
SecondaryChange From Baseline in GLS by ECHO

Global Longitudinal Strain was measured by ECHO at indicated time points. GLS included speckle tracking by ECHO. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Time frame:
Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-up
Reported as:
Mean · Percentage of myocardial shortening
Change From Baseline in GLS by ECHO
Percentage of myocardial shorteningGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
GLS Speckle Tracking, Session 1, Day 24, n=6,1-3.55 ± 5.709-0.90 ± NA
GLS Speckle Tracking, Session 2, Day 24, n=6,0-0.58 ± 6.013—
GLS Speckle Tracking, Session 3, Day 24, n=6,0-1.17 ± 7.487—
GLS Speckle Tracking, Session 4, Day 24, n=5,01.26 ± 5.299—
GLS Speckle Tracking, Session 5, Day 24, n=4,01.13 ± 9.044—
GLS Speckle Tracking, Session 6, Day 24, n=4,0-2.08 ± 4.555—
GLS Speckle Tracking, 8 Week follow-up, n=6,1-1.82 ± 10.0131.60 ± NA
GLS Speckle Tracking, 6 month follow-up, n=4,00.40 ± 4.268—
SecondaryChange From Baseline in LV Twist Over Time

LV twist was measured by CMR at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Time frame:
Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-up
Reported as:
Mean · Degree
Change From Baseline in LV Twist Over Time
DegreeGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
Session 2, Day 24, n=5,00.550 ± 1.6672—
Session 3, Day 24, n=6,00.431 ± 2.4369—
Session 4, Day 24, n=5,0-0.611 ± 1.8979—
Session 5, Day 24, n=4,0-0.628 ± 1.2269—
8 Week follow-up, n=6,1-0.264 ± 2.08350.914 ± NA
6 month follow-up, n=2,0-0.633 ± 0.3349—
SecondaryChange From Baseline in Stroke Volume (SV) by CMR

Stroke volume is the amount of blood ejected by the left ventricle in one contraction. SV was measured by CMR at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Time frame:
Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-up
Reported as:
Mean · Milliliter
Change From Baseline in Stroke Volume (SV) by CMR
MilliliterGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
Session 2, Day 24, n=6,0-2.760 ± 7.8305—
Session 3, Day 24, n=6,0-1.228 ± 24.3834—
Session 4, Day 24, n=5,0-9.766 ± 9.7838—
Session 5, Day 24, n=4,0-11.477 ± 14.4238—
8 Week follow-up, n=6,12.400 ± 19.1252-6.750 ± NA
6 month follow-up, n=2,0-6.160 ± 12.0491—
SecondaryChange From Baseline in SV by ECHO

Stroke volume is the amount of blood ejected by the left ventricle in one contraction. SV was measured by ECHO at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Time frame:
Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-up
Reported as:
Mean · Milliliter
Change From Baseline in SV by ECHO
MilliliterGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
Session 1, Day 24, n=6,12.580 ± 5.4518-5.640 ± NA
Session 2, Day 24, n=6,0-1.885 ± 4.6569—
Session 3, Day 24, n=6,0-1.398 ± 8.0106—
Session 4, Day 24, n=5,0-7.484 ± 6.5228—
Session 5, Day 24, n=4,0-9.043 ± 9.5173—
Session 6, Day 24, n=4,0-5.095 ± 7.1431—
8 Week follow-up, n=6,1-4.343 ± 7.3457-6.490 ± NA
6 month follow-up, n=4,0-4.275 ± 9.9743—
SecondaryChange From Baseline in Left Ventricular Ejection Fraction (EF) by CMR

Left ventricular ejection fraction is a measurement of the percentage of blood leaving the heart each time it contracts. EF was measured by CMR at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Time frame:
Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-up
Reported as:
Mean · Percentage of ejected blood
Change From Baseline in Left Ventricular Ejection Fraction (EF) by CMR
Percentage of ejected bloodGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
Session 2, Day 24, n=6,00.100 ± 3.9071—
Session 3, Day 24, n=6,00.687 ± 11.7171—
Session 4, Day 24, n=5,0-3.380 ± 5.4750—
Session 5, Day 24, n=4,0-3.257 ± 7.9513—
8 Week follow-up, n=6,1-1.258 ± 7.9932-2.800 ± NA
6 month follow-up, n=2,00.680 ± 8.7681—
SecondaryChange From Baseline in Left Ventricular EF by ECHO

Left ventricular ejection fraction is a measurement of the percentage of blood leaving the heart each time it contracts. EF was measured by ECHO at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Time frame:
Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-up
Reported as:
Mean · Percentage of ejected blood
Change From Baseline in Left Ventricular EF by ECHO
Percentage of ejected bloodGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
Session 1, Day 24, n=6,12.10 ± 5.707-7.40 ± NA
Session 2, Day 24, n=6,0-0.38 ± 3.111—
Session 3, Day 24, n=6,0-0.30 ± 3.318—
Session 4, Day 24, n=5,0-2.74 ± 5.766—
Session 5, Day 24, n=4,0-4.05 ± 7.832—
Session 6, Day 24, n=4,0-3.53 ± 3.288—
8 Week follow-up, n=6,1-1.72 ± 8.471-3.20 ± NA
6 month follow-up, n=4,01.20 ± 3.442—
SecondaryChange From Baseline in Left Ventricle End Diastolic Volume (EDV) by CMR

Left ventricle EDV is the volume of blood in the left ventricle at end load or filling in (diastole) or the amount of blood in the ventricles just before systole. EDV was measured by CMR at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Time frame:
Baseline (Day -1) and Session 2 to 5: Day 24; 8 week follow-up; 6 months follow-up
Reported as:
Mean · Milliliter
Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by CMR
MilliliterGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
Session 2, Day 24, n=6,0-3.473 ± 11.2584—
Session 3, Day 24, n=6,01.653 ± 7.3322—
Session 4, Day 24, n=5,0-5.262 ± 5.3765—
Session 5, Day 24, n=4,0-9.323 ± 11.5275—
8 Week follow-up, n=6,19.887 ± 19.3925-4.560 ± NA
6 month follow-up, n=2,0-21.030 ± 8.0469—
SecondaryChange From Baseline in Left Ventricle End Diastolic Volume (EDV) by ECHO

Left ventricle EDV is the volume of blood in the left ventricle at end load or filling in (diastole) or the amount of blood in the ventricles just before systole. EDV was measured by ECHO at indicated time points. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Time frame:
Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-up
Reported as:
Mean · Milliliter
Change From Baseline in Left Ventricle End Diastolic Volume (EDV) by ECHO
MilliliterGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
Session 1, Day 24, n=6,10.050 ± 4.6276-1.790 ± NA
Session 2, Day 24, n=6,0-2.940 ± 10.2320—
Session 3, Day 24, n=6,0-2.922 ± 14.0019—
Session 4, Day 24, n=5,0-12.338 ± 10.2249—
Session 5, Day 24, n=4,0-11.860 ± 14.5676—
Session 6, Day 24, n=4,0-5.073 ± 11.3679—
8 Week follow-up, n=6,1-7.648 ± 4.4630-7.100 ± NA
6 month follow-up, n=4,0-12.045 ± 20.2972—
SecondaryChange From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio)

E/e' ratio was measured by ECHO at indicated time points. It had 2 separate measurements: lateral and septal. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Time frame:
Baseline (Day -1) and Session 1 to 6: Day 24; 8 week follow-up; 6 months follow-up
Reported as:
Mean · Ratio
Change From Baseline in Ratio of Mitral Peak Velocity of Early Filling to Early Diastolic Mitral Annual Velocity (E/e' Ratio)
RatioGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
E/e Lateral Ratio, Session 1, Day 24, n=6,1-1.55 ± 2.813-2.80 ± NA
E/e Lateral Ratio, Session 2, Day 24, n=6,0-0.77 ± 3.555—
E/e Lateral Ratio, Session 3, Day 24, n=6,03.20 ± 2.197—
E/e Lateral Ratio, Session 4, Day 24, n=5,0-0.64 ± 4.750—
E/e Lateral Ratio, Session 5, Day 24, n=4,01.22 ± 5.134—
E/e Lateral Ratio, Session 6, Day 24, n=4,03.25 ± 2.300—
E/e Lateral Ratio, 8 Week follow-up, n=6,10.05 ± 2.6812.90 ± NA
E/e Lateral Ratio, 6 month follow-up, n=4,0-0.58 ± 4.442—
E/e Septal Ratio, Session 1, Day 24, n=6,10.50 ± 2.995-2.00 ± NA
E/e Septal Ratio, Session 2, Day 24, n=6,00.52 ± 4.640—
E/e Septal Ratio, Session 3, Day 24, n=6,05.33 ± 5.136—
E/e Septal Ratio, Session 4, Day 24, n=5,02.96 ± 3.462—
E/e Septal Ratio, Session 5, Day 24, n=4,04.48 ± 3.010—
E/e Septal Ratio, Session 6, Day 24, n=4,06.23 ± 5.917—
E/e Septal Ratio, 8 Week follow-up, n=6,02.83 ± 4.236—
E/e Septal Ratio, 6 month follow-up, n=4,04.95 ± 1.708—

Adverse events

Collected over Non-serious AEs were collected from start of study treatment (Week 0) up to 56 days after the last dosing session (up to 265 days). SAEs were collected from start of the study treatment (Week 0) up to the end of study (Up to 369 days).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants0/6 (0%)2/6 (33.3%)6/6 (100%)
Group 2: Post-chemotherapy AL Amyloidosis Participants0/1 (0%)1/1 (100%)1/1 (100%)
Most frequent serious events
Most frequent serious events
EventGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
VasculitisVascular disorders0/61/1
Transient ischaemic attackNervous system disorders1/60/1
Cardiac failureCardiac disorders1/60/1
Most frequent other events
Showing 10 of 73
Most frequent other events
EventGroup 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis Participants
ConstipationGastrointestinal disorders3/61/1
Dermal cystSkin and subcutaneous tissue disorders0/61/1
Catheter site bruiseGeneral disorders3/61/1
FatigueGeneral disorders3/61/1
Catheter site erythemaGeneral disorders0/61/1
Feeling coldGeneral disorders0/61/1
Muscle spasmsMusculoskeletal and connective tissue disorders1/61/1
SomnolenceNervous system disorders2/61/1
Ventricular tachycardiaCardiac disorders2/61/1
Rash erythematousSkin and subcutaneous tissue disorders3/60/1

Baseline characteristics

No participant was enrolled in "Group 3: Newly diagnosed Mayo stage II/IIIa AL participant" due to early termination of the study.

Age, Continuous
Age, Continuous(Years)Group 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis ParticipantsGroup 3: Newly Diagnosed Mayo Stage II/IIIa AL ParticipantsTotal
Mean74.3 ± 3.2767.0 ± NA—73.3 ± 4.07
Sex: Female, Male
Sex: Female, Male(Participants)Group 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis ParticipantsGroup 3: Newly Diagnosed Mayo Stage II/IIIa AL ParticipantsTotal
Female0000
Male6107
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Group 1: Cardiac TTR Amyloidosis (ATTR-CM) ParticipantsGroup 2: Post-chemotherapy AL Amyloidosis ParticipantsGroup 3: Newly Diagnosed Mayo Stage II/IIIa AL ParticipantsTotal
Race — White/Caucasian/European Heritage6107
08

Study locations

3 sites
  • GSK Investigational Site
    Boston, Massachusetts 02115, United States
  • GSK Investigational Site
    Cambridge, CB2 0GG, United Kingdom
  • GSK Investigational Site
    London, NW10 7EW, United Kingdom
09

References and documents

Study documents

  • Study protocol · Mar 5, 2018
  • Statistical analysis plan · May 1, 2018

Documents are hosted by the registry — open the source record to download them.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2017 to primary completion in Jan 2019, 17 months.

Results were first posted in Oct 2019, 9 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 27, 2016
First posted
Feb 7, 2017
StartActual
Jul 10, 2017
Primary completionActual
Jan 3, 2019
CompletionActual
Jan 3, 2019
Results first posted
Oct 16, 2019
Last update
Oct 16, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03044353
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Feb 7, 2017
Start date
Jul 10, 2017
Primary completion
Jan 3, 2019
Completion
Jan 3, 2019
Results posted
Oct 16, 2019
Last update
Oct 16, 2019

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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