A Phase 1 interventional study of PF-06755347 intravenous healthy participant and Placebo intravenous healthy participant in Healthy, Primary Immune Thrombocytopenia and Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, sponsored by Pfizer. Terminated at 6 sites in 5 countries. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-05.
Sponsored by Pfizer · Phase 1, Interventional, and Treatment
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Among 50 studies in Purpura, Thrombocytopenic, Idiopathic with a site in Spain — 14 open to participants now, 18 under way, 9 of them phase 3. Purpura, Thrombocytopenic, Idiopathic · Spain.
Among the 50 studies in Purpura, Thrombocytopenic, Idiopathic with a site in Spain, this one is the 29th largest by enrollment of the 44 interventional ones that give a count, is one of 2 that started in 2017, is one of 4 in phase 1, and was the 14th registered.
504 studies on the registry are indexed under Purpura, Thrombocytopenic, Idiopathic; 159 are open to participants now.
Browse Purpura, Thrombocytopenic, Idiopathic studies →14 of the 50 studies in Purpura, Thrombocytopenic, Idiopathic with a site in Spain are open now. Recruiting first, the newest first:
TargED Biopharmaceuticals B.V. · Sites in Spain
Ages 18+
CRISPR Therapeutics AG · Sites in Spain, United States, Germany
Ages 18+
Incyte Corporation · Sites in Spain, United States, Australia and 4 more countries
Ages 18+
Sanofi · Sites in Spain, United States, Austria and 7 more countries
Ages 18+
argenx · Sites in Spain, France, Germany and 7 more countries
Ages 12–17
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 103 Purpura, Thrombocytopenic, Idiopathic studies recruiting now, 49 (48%) set no upper age limit and 42 (41%) stop at 75 or younger; 27 take children under 18; 4 take healthy volunteers.
This study: 18 Years to 55 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
50 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 18 · Phase 3 23
First in 2006; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 58 is close to the median of 58 across 377 interventional studies indexed under Purpura, Thrombocytopenic, Idiopathic.
Median enrollment 69 across the 44 interventional studies, 131 across the 6 observational. Of the 31 that completed or were terminated, 21 (68%) have results posted.
This tab as a report to print or save as PDF → With an account.
45 of 50 have an industry lead sponsor. The 10 most frequent:
Pfizer is the lead sponsor of 3,337 studies on the registry; 150 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 392 (65%) have results posted.
Pfizer has 2 studies filed under Purpura, Thrombocytopenic, Idiopathic — fewer than ten, so there is no comparison to draw.
5 of the studies in Purpura, Thrombocytopenic, Idiopathic with a site in Spain that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07059000Phase 3Kedrion S.p.A.A Study Investigating Intravenous Human Normal Immunoglobulin 10% in Adults With Chronic Immune Thrombocytopenia (ITP) | 2026-12 |
| NCT07007962Phase 3SanofiStudy to Evaluate the Efficacy and Safety of Oral Rilzabrutinib in Adults With Immune Thrombocytopenia (ITP) Who Failed First-line Treatment | 2027-11-05 |
| NCT06371417Chugai PharmaceuticalPhase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial) | 2027-03-31 |
| NCT07043946Climb Bio, Inc.A Phase 1b/2a Study of Budoprutug in Subjects With Immune Thrombocytopenia (ITP) | 2027-08 |
| NCT07104565Incyte CorporationStudy to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders | 2027-09-23 |
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Among the 50 studies in Purpura, Thrombocytopenic, Idiopathic with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This phase 1 single ascending dose study will provide a first in human assessment of safety and tolerability of PF-06755347 in healthy adult males as well as adult males and females with Immune Thrombocytopenia (ITP). Pharmacokinetics and pharmacodynamics will also be evaluated.
Inclusion Criteria Healthy male participants:
Exclusion Criteria for Healthy male participants:
Female participants may be of or non-childbearing potential.
-Diagnosis of Primary ITP. ITP must be diagnosed in accordance with established guidelines. ITP duration-Persistent (>3 months and ≤12 months) OR Chronic (>12 months).
AND
Participants must have received and responded to IVIg or as treatment for ITP (response is defined as achievement of platelet count >50 x 109/L and doubling of platelet count from baseline).
--Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
Exclusion Criteria for ITP participants
Chest x-ray must be taken at Screening or within 3 months prior to Screening and read by a qualified radiologist.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
intravenous administration
Drug: PF-06755347 intravenous healthy participant
intravenous administration
Drug: Placebo intravenous healthy participant
subcutaneous administration
Drug: PF-06755347 subcutaneous healthy participant
subcutaneous administration
Drug: Placebo subcutaneous healthy participant
subcutaneous
Drug: PF-06755347 subcutaneous ITP
Single doses of PF-06755347 will be administered intravenously dose levels 1, 2, 3, 4, 5, and 6.
Placebo comparator
single doses of PF-06755347 will be administered subcutaneously at dose levels of SC1, SC2, SC3, SC4, and SC5.
placebo comparator
single doses of PF-06755347 will be administered subcutaneously at 2 dose levels tested in healthy participants
Number of Participants With All-causality Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, Treatment-related TEAEs, and Discontinuations From Study Due to TEAEs
Adverse event (AE) was any untoward medical occurrence in the participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Serious AE was any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or was considered to be an important medical event. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent. AEs included both serious and non-serious AEs.
Time frame: Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).
Number of Participants With Laboratory Test Abnormalities
Laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, absolute and percent total neutrophils, eosinophils, monocytes, basophils and lymphocytes),chemistry (blood urea nitrogen/urea and creatinine, fasting glucose, calcium, sodium, potassium, chloride, total carbon dioxide, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin and total protein),urinalysis(pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy, urinary albumin to creatinine ratio and urinary protein to creatinine ratio) and other tests. Abnormality was determined by the investigator. Only lab abnormalities with at least 1 occurrence in participants are reported.
Time frame: Baseline, Study Days 1, 2, 4, 6, 8, 11, 15, 22, 29 and 36 for IV treatment cohorts, and Baseline, Study Days 1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 50 and 71 for SC treatment cohorts.
Number of Participants With Vital Signs Meeting Categorical Criteria
Supine blood pressure and pulse rate were measured. Categorical classes for vital signs of potential clinical concerns were defined as followed: systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg); diastolic blood pressure (DBP) \<50 mmHg; pulse rate \<40 beats per minute (bpm); pulse rate \>120 bpm, and increase from baseline in SBP ≥30 mmHg; decrease from baseline in SBP ≥30 mmHg; increase from baseline in DBP ≥20 mmHg; decrease from baseline in DBP ≥20 mmHg. Baseline was defined as the mean of the replicated predose (0 hour) measurement on Day 1.
Time frame: Baseline, Study Days 1, 2, 4, 6, 8, 11, 15, 22, 29 and 36 for IV treatment cohorts, and Baseline, Study Days 1, 2, 3, 4, 6, 8, 11, 15, 22, 29, 36, 50 and 71 for SC treatment cohorts.
Number of Participants With Electrocardiograms (ECGs) Meeting Categorical Criteria
Number of participants with ECG findings meeting the following criteria: time between the onset of atrial depolarization and onset of ventricular depolarization (PR interval) ≥300 msec; time from ECG Q-wave to the end of the S wave corresponding to ventricular depolarization (QRS duration) ≥140 msec; correct time from ECG Q-wave to the end of the T wave corresponding to electrical systole for heart rate using Fridericia's formula (QTcF interval): ≥450 to \<480 msec; QTcF interval ≥480 to \<500 msec; QTcF interval: ≥500 msec; PR interval percent change from baseline (≥25/50%): ≥25% if baseline \>200 msec or ≥ 50% if baseline ≤200 msec; QRS duration percent change from baseline ≥50%; QTcF interval change from baseline: \>30 to ≤60 msec; QTcF interval change from baseline \>60 msec. Baseline was defined as the average of the triplicate predose recordings collected at 0 hour on Day 1.
Time frame: Baseline (Study Day 1, predose), Study Days 1 (postdose), 2, 4, 6, 8, 11, 22, 36 (end of study visit for IV treatment cohorts) and 71 (end of study visit for SC treatment cohorts).
Maximum Plasma Concentration (Cmax) of PF-06755347 Following Single IV Dose
Cmax was the highest concentration observed directly from data
Time frame: Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.
Cmax of PF-06755347 Following Single SC Dose
Cmax was the highest concentration observed directly from data
Time frame: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Dose Normalized Cmax (Cmax(dn)) of PF-06755347 Following Single IV Dose
Cmax(dn) = Cmax/Dose
Time frame: Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.
Cmax(dn) of PF-06755347 Following Single SC Dose
Cmax(dn) = Cmax/Dose
Time frame: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Time for Cmax (Tmax) of PF-06755347 Following Single IV Dose
Tmax was the time to reach maximum observed plasma concentration, which was observed directly from data as time of first occurrence.
Time frame: Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.
Tmax of PF-06755347 Following Single SC Dose
Tmax was the time to reach maximum observed plasma concentration, which was observed directly from data as time of first occurrence.
Time frame: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Area Under the Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06755347 Following Single IV Dose
AUClast was determined using linear/Log trapezoidal method
Time frame: Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.
AUClast of PF-06755347 Following Single SC Dose
AUClast was determined using linear/Log trapezoidal method
Time frame: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Dose Normalized AUClast (AUClast(dn)) of PF-06755347 Following Single IV Dose
AUClast(dn) = AUClast/Dose
Time frame: Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.
AUClast(dn) of PF-06755347 Following Single SC Dose
AUClast(dn) = AUClast/Dose
Time frame: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Area Under the Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06755347 Following Single IV Dose
AUClast + (Clast\*/kel), where Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Time frame: Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.
AUCinf of PF-06755347 Following Single SC Dose
AUClast + (Clast\*/kel), where Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Time frame: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Dose Normalized AUCinf (AUCinf(dn)) of PF-06755347 Following Single IV Dose
AUCinf(dn) = AUCinf/Dose
Time frame: Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.
AUCinf(dn) of PF-06755347 Following Single SC Dose
AUCinf(dn) = AUCinf/Dose
Time frame: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Terminal Half-life (t½) of PF-06755347 Following Single IV Dose
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t½ = Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Time frame: Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.
t½ of PF-06755347 Following Single SC Dose
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t½ = Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Time frame: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Clearance (CL) of PF-06755347 Following Single IV Dose
CL = Dose/AUCinf Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of study drug.
Time frame: Hours 0, 1, 3, 5, 8, 12, 24, 48, 72, 120, and 168 for every cohort, hour 36 for Cohorts 1 and 2, Days 15, 22, 29, and 36 for Cohorts 3-6, hours 3.5, 4, and 6 for Cohorts 5 and 6.
Apparent Clearance (CL/F) of PF-06755347 Following Single SC Dose
CL/F = Dose/AUCinf Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Time frame: Hours 0, 12, 24, 48, 72, 120, and 168, and Days 5, 11, 15, 22, 29, 36, 50 and 71.
Number of Participants With Positive Anti-Drug Antibody to PF-06755347
Human serum samples were analyzed for the presence or absence of anti-PF-06755347 antibodies (ADA) following a tiered approach of screening, confirmation and titer determination, using an electrochemiluminescent (ECL) immunoassay. Baseline was the measurement on Day -1.
Time frame: Baseline, Study Days 8, 15, and 36 for all treatment cohorts plus Day 71 for SC treatment cohorts
Change From Baseline in Interferon Gamma (IFN-γ ) at Scheduled Timepoints
IFN-γ was one of the 3 cytokine biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1.
Time frame: Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts.
Change From Baseline in Tumor Necrosis Factor Alpha (TNFα) at Scheduled Timepoints
TNFα was one of the 3 cytokine biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1.
Time frame: Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts.
Change From Baseline in Interleukin 6 (IL-6) at Scheduled Timepoints
IL-6 was one of the 3 cytokine biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1.
Time frame: Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts.
Change From Baseline in Complement 3a (C3a) at Scheduled Timepoints
C3a was one of the 3 complement components/biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1.
Time frame: Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts.
Change From Baseline in Complement 5a (C5a) at Scheduled Timepoints
C5a was one of the 3 complement components/biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1.
Time frame: Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts.
Change From Baseline in Activated Factor B (Bb) at Scheduled Timepoints
Bb was one of the complement components/biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1.
Time frame: Day -1, hours 0, 5, 12, 24, 48, 72 for all treatment cohorts. Hours 1 (or end of infusion), 8, and 120 and Days 11 and 29 for IV treatment cohorts; Days 5, 8, 15, 36 and 71 for SC treatment cohorts.
The study planned 14 cohorts, however, it was terminated due to non-safety reasons during Cohort 11, with no further enrollment. Included in this study were all healthy participants, who were randomized to either receive PF-06755347 or placebo by intravenous (IV) or subcutaneous (SC) administration in a 3:1 allocation ratio. A total of 58 participants were dosed in this study: 42 received PF-06755347 and 16 received placebo.
| Milestone | Cohort 1: PF-06755347 0.01 mg/kg IV | Cohort 2: PF-06755347 0.03 mg/kg IV | Cohort 3: PF-06755347 0.1 mg/kg IV | Cohort 4: PF-06755347 0.3 mg/kg IV | Cohort 5: PF-06755347 1 mg/kg IV | Cohort 6: PF-06755347 0.7 mg/kg IV | Cohort 7: PF-06755347 25 mg SC | Cohort 8: PF-06755347 50 mg SC | Cohort 9: PF-06755347 100 mg SC | Cohort 10: PF-06755347 200 mg SC | Cohort 11: PF-06755347 300 mg SC | Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 6 | 6 | 6 | 3 | 16 |
| Completed | 3 | 3 | 3 | 3 | 2 | 2 | 3 | 6 | 5 | 5 | 3 | 16 |
| Not completed | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 1 | 0 | 0 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Due to coronaviras disease 2019 (covid-19) pandemic | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
Adverse event (AE) was any untoward medical occurrence in the participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Serious AE was any untoward medical occurrence that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or was considered to be an important medical event. Any events occurring following start of treatment or increasing in severity were counted as treatment-emergent. AEs included both serious and non-serious AEs.
| Participants | Cohort 1: PF-06755347 0.01 mg/kg IV | Cohort 2: PF-06755347 0.03 mg/kg IV | Cohort 3: PF-06755347 0.1 mg/kg IV | Cohort 4: PF-06755347 0.3 mg/kg IV | Cohort 5: PF-06755347 1 mg/kg IV | Cohort 6: PF-06755347 0.7 mg/kg IV | Cohort 7: PF-06755347 25 mg SC | Cohort 8: PF-06755347 50 mg SC | Cohort 9: PF-06755347 100 mg SC | Cohort 10: PF-06755347 200 mg SC | Cohort 11: PF-06755347 300 mg SC | Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| All-causality TEAEs | 3 | 2 | 3 | 3 | 3 | 3 | 3 | 6 | 6 | 5 | 3 | 10 |
| Serious TEAEs | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Treatment-related TEAEs | 2 | 2 | 2 | 2 | 3 | 3 | 2 | 5 | 6 | 4 | 3 | 7 |
| Discontinuations from study due to TEAEs | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Laboratory test included: hematology (hemoglobin, hematocrit, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, white blood cell count, absolute and percent total neutrophils, eosinophils, monocytes, basophils and lymphocytes),chemistry (blood urea nitrogen/urea and creatinine, fasting glucose, calcium, sodium, potassium, chloride, total carbon dioxide, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin and total protein),urinalysis(pH, qualitative glucose, qualitative protein, qualitative blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy, urinary albumin to creatinine ratio and urinary protein to creatinine ratio) and other tests. Abnormality was determined by the investigator. Only lab abnormalities with at least 1 occurrence in participants are reported.
| Participants | Cohort 1: PF-06755347 0.01 mg/kg IV | Cohort 2: PF-06755347 0.03 mg/kg IV | Cohort 3: PF-06755347 0.1 mg/kg IV | Cohort 4: PF-06755347 0.3 mg/kg IV | Cohort 5: PF-06755347 1 mg/kg IV | Cohort 6: PF-06755347 0.7 mg/kg IV | Cohort 7: PF-06755347 25 mg SC | Cohort 8: PF-06755347 50 mg SC | Cohort 9: PF-06755347 100 mg SC | Cohort 10: PF-06755347 200 mg SC | Cohort 11: PF-06755347 300 mg SC | Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean Platelet Volume > 1.1 x upper limit of normal (ULN) | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 3 |
| Ery. Mean Corpuscular Volume <0.9 x lower limit of normal (LLN) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 |
| Leukocytes <0.6 x LLN | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Lymphocytes <0.8 x LLN | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 1 | 0 | 1 | 1 |
| Ery. Mean Corpuscular Hemoglobin < 0.9 x LLN | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Lymphocytes/ Leukocytes >1.2 x ULN | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Neutrophils <0.8 x LLN | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 2 | 0 | 0 |
| Neutrophils >1.2 x ULN | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Eosinophils >1.2 x ULN | 1 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 1 |
| Eosinophils/Leukocytes >1.2 x ULN | 1 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 1 |
| Monocytes >1.2 x ULN | 1 | 0 | 0 | 2 | 0 | 2 | 0 | 0 | 1 | 0 | 1 | 2 |
| Monocytes/Leukocytes >1.2 x ULN | 0 | 1 | 0 | 0 | 0 | 2 | 2 | 2 | 0 | 1 | 1 | 1 |
| Bilirubin >1.5 x ULN | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Direct Bilirubin >1.5 x ULN | 0 | 1 | 0 | 1 | 0 | 0 | 2 | 1 | 1 | 0 | 0 | 0 |
| Aspartate Aminotransferase >3.0 x ULN | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Urea >1.3 x ULN | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Urate >1.2 x ULN | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Creatine Kinase >2.0 x ULN | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| C Reactive Protein >1.1 x ULN | 0 | 0 | 0 | 0 | 1 | 3 | 1 | 2 | 2 | 3 | 2 | 0 |
| Bicarbonate >1.1 x ULN | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
| D-Dimer >1.5 x ULN | 0 | 1 | 0 | 0 | 3 | 2 | 0 | 1 | 1 | 2 | 0 | 1 |
| Fibrinogen >1.25 x ULN | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Specific Gravity <1.003 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 |
| Specific Gravity >1.030 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| pH >8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Ketones ≥1 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 3 | 2 | 0 | 0 | 1 |
| URINE Protein ≥1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| URINE Hemoglobin ≥1 | 1 | 1 | 2 | 1 | 1 | 0 | 0 | 0 | 2 | 0 | 1 | 1 |
| Urobilinogen ≥1 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 1 | 0 | 1 | 0 | 1 |
| URINE Bilirubin ≥1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 |
| Nitrite ≥1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
| Leukocyte Esterase ≥1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
Supine blood pressure and pulse rate were measured. Categorical classes for vital signs of potential clinical concerns were defined as followed: systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg); diastolic blood pressure (DBP) \<50 mmHg; pulse rate \<40 beats per minute (bpm); pulse rate \>120 bpm, and increase from baseline in SBP ≥30 mmHg; decrease from baseline in SBP ≥30 mmHg; increase from baseline in DBP ≥20 mmHg; decrease from baseline in DBP ≥20 mmHg. Baseline was defined as the mean of the replicated predose (0 hour) measurement on Day 1.
| Participants | Cohort 1: PF-06755347 0.01 mg/kg IV | Cohort 2: PF-06755347 0.03 mg/kg IV | Cohort 3: PF-06755347 0.1 mg/kg IV | Cohort 4: PF-06755347 0.3 mg/kg IV | Cohort 5: PF-06755347 1 mg/kg IV | Cohort 6: PF-06755347 0.7 mg/kg IV | Cohort 7: PF-06755347 25 mg SC | Cohort 8: PF-06755347 50 mg SC | Cohort 9: PF-06755347 100 mg SC | Cohort 10: PF-06755347 200 mg SC | Cohort 11: PF-06755347 300 mg SC | Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pulse rate <40 bpm | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 6 | 5 | 3 | 0 |
| Pulse rate >120 bpm | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| DBP <50 mmHg | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| DBP: increase from baseline ≥20 mmHg | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 3 | 1 | 1 | 0 |
| DBP: decrease from baseline ≥20 mmHg | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| SBP <90 mmHg | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| SBP: increase from baseline ≥30 mmHg | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| SBP: decrease from baseline ≥30 mmHg | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Number of participants with ECG findings meeting the following criteria: time between the onset of atrial depolarization and onset of ventricular depolarization (PR interval) ≥300 msec; time from ECG Q-wave to the end of the S wave corresponding to ventricular depolarization (QRS duration) ≥140 msec; correct time from ECG Q-wave to the end of the T wave corresponding to electrical systole for heart rate using Fridericia's formula (QTcF interval): ≥450 to \<480 msec; QTcF interval ≥480 to \<500 msec; QTcF interval: ≥500 msec; PR interval percent change from baseline (≥25/50%): ≥25% if baseline \>200 msec or ≥ 50% if baseline ≤200 msec; QRS duration percent change from baseline ≥50%; QTcF interval change from baseline: \>30 to ≤60 msec; QTcF interval change from baseline \>60 msec. Baseline was defined as the average of the triplicate predose recordings collected at 0 hour on Day 1.
| Participants | Cohort 1: PF-06755347 0.01 mg/kg IV | Cohort 2: PF-06755347 0.03 mg/kg IV | Cohort 3: PF-06755347 0.1 mg/kg IV | Cohort 4: PF-06755347 0.3 mg/kg IV | Cohort 5: PF-06755347 1 mg/kg IV | Cohort 6: PF-06755347 0.7 mg/kg IV | Cohort 7: PF-06755347 25 mg SC | Cohort 8: PF-06755347 50 mg SC | Cohort 9: PF-06755347 100 mg SC | Cohort 10: PF-06755347 200 mg SC | Cohort 11: PF-06755347 300 mg SC | Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PR interval ≥300 msec | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| PR interval: percent change from baseline ≥25/50% | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| QRS duration ≥140 msec | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| QRS duration: percent change from baseline ≥50% | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| QTcF interval: ≥450 to <480 msec | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| QTcF interval: ≥480 to <500 msec | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| QTcF interval ≥500 msec | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| QTcF interval change from baseline: >30 msec to ≤60 msec | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| QTcF interval change from baseline: >60 msec | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Cmax was the highest concentration observed directly from data
| micrograms/milliliter (ug/mL) | Cohort 1: PF-06755347 0.01 mg/kg IV | Cohort 2: PF-06755347 0.03 mg/kg IV | Cohort 3: PF-06755347 0.1 mg/kg IV | Cohort 4: PF-06755347 0.3 mg/kg IV | Cohort 5: PF-06755347 1 mg/kg IV | Cohort 6: PF-06755347 0.7 mg/kg IV |
|---|---|---|---|---|---|---|
| Maximum Plasma Concentration (Cmax) of PF-06755347 Following Single IV Dose | 0.1123 ± 18 | 0.4462 ± 20 | 1.654 ± 10 | 4.700 ± 9 | 24.72 ± 21 | 12.36 ± 9 |
Cmax was the highest concentration observed directly from data
| ug/mL | Cohort 7: PF-06755347 25 mg SC | Cohort 8: PF-06755347 50 mg SC | Cohort 9: PF-06755347 100 mg SC | Cohort 10: PF-06755347 200 mg SC | Cohort 11: PF-06755347 300 mg SC |
|---|---|---|---|---|---|
| Cmax of PF-06755347 Following Single SC Dose | 0.8946 ± 25 | 1.374 ± 68 | 2.641 ± 40 | 5.678 ± 15 | 5.276 ± 47 |
Cmax(dn) = Cmax/Dose
| ug/mL/(miligrams/kilogram [mg/kg]) | Cohort 1: PF-06755347 0.01 mg/kg IV | Cohort 2: PF-06755347 0.03 mg/kg IV | Cohort 3: PF-06755347 0.1 mg/kg IV | Cohort 4: PF-06755347 0.3 mg/kg IV | Cohort 5: PF-06755347 1 mg/kg IV | Cohort 6: PF-06755347 0.7 mg/kg IV |
|---|---|---|---|---|---|---|
| Dose Normalized Cmax (Cmax(dn)) of PF-06755347 Following Single IV Dose | 11.23 ± 18 | 14.88 ± 20 | 16.54 ± 10 | 15.69 ± 9 | 24.72 ± 21 | 17.68 ± 9 |
Cmax(dn) = Cmax/Dose
| ug/mL/(mg/kg) | Cohort 7: PF-06755347 25 mg SC | Cohort 8: PF-06755347 50 mg SC | Cohort 9: PF-06755347 100 mg SC | Cohort 10: PF-06755347 200 mg SC | Cohort 11: PF-06755347 300 mg SC |
|---|---|---|---|---|---|
| Cmax(dn) of PF-06755347 Following Single SC Dose | 0.03579 ± 25 | 0.02748 ± 68 | 0.02641 ± 40 | 0.02842 ± 15 | 5.276 ± 0.01758 |
Tmax was the time to reach maximum observed plasma concentration, which was observed directly from data as time of first occurrence.
| hours | Cohort 1: PF-06755347 0.01 mg/kg IV | Cohort 2: PF-06755347 0.03 mg/kg IV | Cohort 3: PF-06755347 0.1 mg/kg IV | Cohort 4: PF-06755347 0.3 mg/kg IV | Cohort 5: PF-06755347 1 mg/kg IV | Cohort 6: PF-06755347 0.7 mg/kg IV |
|---|---|---|---|---|---|---|
| Time for Cmax (Tmax) of PF-06755347 Following Single IV Dose | 1.270 (1.22 to 1.30) | 1.050 (1.05 to 1.08) | 1.180 (1.17 to 1.18) | 1.180 (1.18 to 1.18) | 1.170 (1.17 to 3.30) | 3.020 (1.00 to 3.03) |
Tmax was the time to reach maximum observed plasma concentration, which was observed directly from data as time of first occurrence.
| hours | Cohort 7: PF-06755347 25 mg SC | Cohort 8: PF-06755347 50 mg SC | Cohort 9: PF-06755347 100 mg SC | Cohort 10: PF-06755347 200 mg SC | Cohort 11: PF-06755347 300 mg SC |
|---|---|---|---|---|---|
| Tmax of PF-06755347 Following Single SC Dose | 48.00 (48.00 to 72.00) | 48.00 (48.00 to 48.90) | 60.05 (48.00 to 96.00) | 48.00 (24.00 to 96.00) | 72.00 (48.00 to 120.00) |
AUClast was determined using linear/Log trapezoidal method
| micrograms*hour/milliliter (ug*hr/mL) | Cohort 1: PF-06755347 0.01 mg/kg IV | Cohort 2: PF-06755347 0.03 mg/kg IV | Cohort 3: PF-06755347 0.1 mg/kg IV | Cohort 4: PF-06755347 0.3 mg/kg IV | Cohort 5: PF-06755347 1 mg/kg IV | Cohort 6: PF-06755347 0.7 mg/kg IV |
|---|---|---|---|---|---|---|
| Area Under the Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-06755347 Following Single IV Dose | 1.395 ± 70 | 10.51 ± 30 | 45.18 ± 9 | 156.4 ± 7 | 511.8 ± 29 | 316.2 ± 3 |
AUClast was determined using linear/Log trapezoidal method
| ug*hr/mL | Cohort 7: PF-06755347 25 mg SC | Cohort 8: PF-06755347 50 mg SC | Cohort 9: PF-06755347 100 mg SC | Cohort 10: PF-06755347 200 mg SC | Cohort 11: PF-06755347 300 mg SC |
|---|---|---|---|---|---|
| AUClast of PF-06755347 Following Single SC Dose | 125.4 ± 12 | 230.2 ± 42 | 428.7 ± 24 | 859.5 ± 13 | 977.6 ± 30 |
AUClast(dn) = AUClast/Dose
| ug*hr/mL/(mg/kg) | Cohort 1: PF-06755347 0.01 mg/kg IV | Cohort 2: PF-06755347 0.03 mg/kg IV | Cohort 3: PF-06755347 0.1 mg/kg IV | Cohort 4: PF-06755347 0.3 mg/kg IV | Cohort 5: PF-06755347 1 mg/kg IV | Cohort 6: PF-06755347 0.7 mg/kg IV |
|---|---|---|---|---|---|---|
| Dose Normalized AUClast (AUClast(dn)) of PF-06755347 Following Single IV Dose | 139.5 ± 70 | 349.8 ± 30 | 451.8 ± 9 | 521.1 ± 7 | 511.8 ± 29 | 451.8 ± 3 |
AUClast(dn) = AUClast/Dose
| ug*hr/mL/(mg/kg) | Cohort 7: PF-06755347 25 mg SC | Cohort 8: PF-06755347 50 mg SC | Cohort 9: PF-06755347 100 mg SC | Cohort 10: PF-06755347 200 mg SC | Cohort 11: PF-06755347 300 mg SC |
|---|---|---|---|---|---|
| AUClast(dn) of PF-06755347 Following Single SC Dose | 5.010 ± 13 | 4.603 ± 42 | 4.287 ± 24 | 4.297 ± 13 | 3.263 ± 30 |
AUClast + (Clast\*/kel), where Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
| ug*hr/mL | Cohort 1: PF-06755347 0.01 mg/kg IV | Cohort 2: PF-06755347 0.03 mg/kg IV | Cohort 3: PF-06755347 0.1 mg/kg IV | Cohort 4: PF-06755347 0.3 mg/kg IV | Cohort 5: PF-06755347 1 mg/kg IV | Cohort 6: PF-06755347 0.7 mg/kg IV |
|---|---|---|---|---|---|---|
| Area Under the Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06755347 Following Single IV Dose | — | 12.52 ± 25 | 49.35 ± 10 | 162.7 ± 8 | 569.7 ± 29 | NA ± NA |
AUClast + (Clast\*/kel), where Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
| ug*hr/mL | Cohort 7: PF-06755347 25 mg SC | Cohort 8: PF-06755347 50 mg SC | Cohort 9: PF-06755347 100 mg SC | Cohort 10: PF-06755347 200 mg SC | Cohort 11: PF-06755347 300 mg SC |
|---|---|---|---|---|---|
| AUCinf of PF-06755347 Following Single SC Dose | 133.2 ± 10 | 234.7 ± 42 | 440.1 ± 25 | 861.3 ± 15 | 988.8 ± 30 |
AUCinf(dn) = AUCinf/Dose
| ug*hr/mL/mg | Cohort 1: PF-06755347 0.01 mg/kg IV | Cohort 2: PF-06755347 0.03 mg/kg IV | Cohort 3: PF-06755347 0.1 mg/kg IV | Cohort 4: PF-06755347 0.3 mg/kg IV | Cohort 5: PF-06755347 1 mg/kg IV | Cohort 6: PF-06755347 0.7 mg/kg IV |
|---|---|---|---|---|---|---|
| Dose Normalized AUCinf (AUCinf(dn)) of PF-06755347 Following Single IV Dose | — | 417.5 ± 25 | 493.5 ± 10 | 541.9 ± 8 | 569.7 ± 29 | NA ± NA |
AUCinf(dn) = AUCinf/Dose
| ug*hr/mL/mg | Cohort 7: PF-06755347 25 mg SC | Cohort 8: PF-06755347 50 mg SC | Cohort 9: PF-06755347 100 mg SC | Cohort 10: PF-06755347 200 mg SC | Cohort 11: PF-06755347 300 mg SC |
|---|---|---|---|---|---|
| AUCinf(dn) of PF-06755347 Following Single SC Dose | 5.323 ± 11 | 4.695 ± 42 | 4.401 ± 25 | 4.305 ± 15 | 3.295 ± 30 |
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t½ = Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
| hours | Cohort 1: PF-06755347 0.01 mg/kg IV | Cohort 2: PF-06755347 0.03 mg/kg IV | Cohort 3: PF-06755347 0.1 mg/kg IV | Cohort 4: PF-06755347 0.3 mg/kg IV | Cohort 5: PF-06755347 1 mg/kg IV | Cohort 6: PF-06755347 0.7 mg/kg IV |
|---|---|---|---|---|---|---|
| Terminal Half-life (t½) of PF-06755347 Following Single IV Dose | — | 34.20 ± 7.3082 | 51.10 ± 4.7624 | 77.17 ± 0.40415 | 70.90 ± 12.150 | NA ± NA |
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. t½ = Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
| hours | Cohort 7: PF-06755347 25 mg SC | Cohort 8: PF-06755347 50 mg SC | Cohort 9: PF-06755347 100 mg SC | Cohort 10: PF-06755347 200 mg SC | Cohort 11: PF-06755347 300 mg SC |
|---|---|---|---|---|---|
| t½ of PF-06755347 Following Single SC Dose | 94.13 ± 32.843 | 135.6 ± 56.409 | 82.88 ± 19.498 | 100.1 ± 18.940 | 139.3 ± 9.8658 |
CL = Dose/AUCinf Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of study drug.
| L/hr/kg | Cohort 1: PF-06755347 0.01 mg/kg IV | Cohort 2: PF-06755347 0.03 mg/kg IV | Cohort 3: PF-06755347 0.1 mg/kg IV | Cohort 4: PF-06755347 0.3 mg/kg IV | Cohort 5: PF-06755347 1 mg/kg IV | Cohort 6: PF-06755347 0.7 mg/kg IV |
|---|---|---|---|---|---|---|
| Clearance (CL) of PF-06755347 Following Single IV Dose | — | 0.002397 ± 25 | 0.002027 ± 10 | 0.001846 ± 8 | 0.001758 ± 29 | NA ± NA |
CL/F = Dose/AUCinf Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population PK modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
| L/hr | Cohort 7: PF-06755347 25 mg SC | Cohort 8: PF-06755347 50 mg SC | Cohort 9: PF-06755347 100 mg SC | Cohort 10: PF-06755347 200 mg SC | Cohort 11: PF-06755347 300 mg SC |
|---|---|---|---|---|---|
| Apparent Clearance (CL/F) of PF-06755347 Following Single SC Dose | 0.1876 ± 11 | 0.2128 ± 42 | 0.2272 ± 25 | 0.2321 ± 15 | 0.3036 ± 30 |
Human serum samples were analyzed for the presence or absence of anti-PF-06755347 antibodies (ADA) following a tiered approach of screening, confirmation and titer determination, using an electrochemiluminescent (ECL) immunoassay. Baseline was the measurement on Day -1.
| Participants | Cohort 1: PF-06755347 0.01 mg/kg IV | Cohort 2: PF-06755347 0.03 mg/kg IV | Cohort 3: PF-06755347 0.1 mg/kg IV | Cohort 4: PF-06755347 0.3 mg/kg IV | Cohort 5: PF-06755347 1 mg/kg IV | Cohort 6: PF-06755347 0.7 mg/kg IV | Cohort 7: PF-06755347 25 mg SC | Cohort 8: PF-06755347 50 mg SC | Cohort 9: PF-06755347 100 mg SC | Cohort 10: PF-06755347 200 mg SC | Cohort 11: PF-06755347 300 mg SC | Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline postive ADA | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 3 |
| Day 8 positive ADA | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
| Day 15 positive ADA | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 2 |
| Day 36 positive ADA | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 2 |
| Day 71 positive ADA | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 |
IFN-γ was one of the 3 cytokine biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1.
| nanograms per liter (ng/L) | Cohort 1: PF-06755347 0.01 mg/kg IV | Cohort 2: PF-06755347 0.03 mg/kg IV | Cohort 3: PF-06755347 0.1 mg/kg IV | Cohort 4: PF-06755347 0.3 mg/kg IV | Cohort 5: PF-06755347 1 mg/kg IV | Cohort 6: PF-06755347 0.7 mg/kg IV | Cohort 7: PF-06755347 25 mg SC | Cohort 8: PF-06755347 50 mg SC | Cohort 9: PF-06755347 100 mg SC | Cohort 10: PF-06755347 200 mg SC | Cohort 11: PF-06755347 300 mg SC | Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1: 1 hour post-dose | -0.303 ± 0.0950 | -3.230 ± 5.0126 | -0.337 ± 0.5686 | 3.903 ± 3.7969 | 20.240 ± 14.2259 | 26.157 ± 17.0904 | -0.423 ± 0.2454 | -0.145 ± 0.8771 | -0.030 ± NA | — | — | -0.554 ± 0.4981 |
| Day 1: 3 hours post-dose | -0.440 ± 0.7134 | -0.293 ± 3.4514 | 24.490 ± 22.6078 | 50.667 ± 29.7923 | 292.287 ± 233.1423 | 250.257 ± 301.3490 | -0.403 ± 0.4239 | 0.295 ± 0.8520 | 0.330 ± NA | — | — | -0.448 ± 0.4631 |
| Day 1: 5 hours post-dose | 0.383 ± 1.2687 | -1.227 ± 5.1897 | 16.790 ± 13.5079 | 21.467 ± 11.4311 | 160.287 ± 157.2547 | 41.575 ± 15.6624 | 0.223 ± 1.2471 | 4.155 ± 10.1704 | 4.403 ± 5.7437 | 53.540 ± 65.4359 | 14.793 ± 7.5312 | -0.337 ± 0.7686 |
| Day 1: 8 hours post-dose | — | — | — | — | 86.700 ± NA | 9.975 ± 1.5910 | 1.373 ± 1.9731 | 5.012 ± 12.0362 | 14.400 ± NA | — | — | -0.422 ± 0.4181 |
| Day 1: 12 hours post-dose | — | — | — | — | 32.100 ± NA | 4.125 ± 7.9550 | 2.477 ± 2.8330 | 4.230 ± 7.9003 | 11.207 ± 5.8049 | 12.345 ± 4.5839 | 8.327 ± 6.7983 | -0.155 ± 0.8139 |
| Day 2: 24 hours post-dose | 0.430 ± 2.1622 | -1.750 ± 4.2354 | -0.403 ± 0.8138 | -0.317 ± 0.3868 | -12.533 ± 21.7084 | 21.075 ± 44.2295 | 2.340 ± 3.1990 | 2.402 ± 2.8296 | 3.322 ± 2.1890 | 3.283 ± 1.6786 | -3.257 ± 9.1184 | 1.027 ± 3.3372 |
| Day 3: 48 hours post-dose | 5.400 ± 11.9840 | -4.707 ± 8.0587 | -0.083 ± 0.1893 | -0.497 ± 0.4405 | -8.733 ± 15.1266 | 2.663 ± 14.6931 | 2.820 ± 5.9672 | 1.333 ± 4.4335 | 2.937 ± 3.8441 | 1.563 ± 0.9806 | -5.300 ± 9.5979 | 12.843 ± 50.7623 |
| Day 4: 72 hours post-dose | 2.877 ± 8.4727 | -4.893 ± 8.0609 | -0.433 ± 1.0587 | -0.363 ± 0.3702 | -15.327 ± 26.5466 | -3.660 ± 5.9789 | 1.197 ± 2.2445 | -2.492 ± 8.4374 | 0.968 ± 2.5824 | 0.552 ± 1.0780 | -6.063 ± 10.1365 | 27.946 ± 111.802 |
| Day 5: 96 hours post-dose | — | — | — | — | — | — | — | — | 0.558 ± 2.0766 | 8.516 ± 15.1062 | -6.123 ± 10.0962 | 1.118 ± 1.5380 |
| Day 8: 168 hours post-dose | -0.817 ± 2.8587 | -8.260 ± 13.1193 | -0.487 ± 0.7658 | -0.230 ± 0.3279 | -16.247 ± 28.1401 | -3.290 ± 3.3698 | -0.160 ± 1.5159 | -3.900 ± 12.0196 | -2.040 ± 3.6754 | -0.344 ± 0.9542 | -5.457 ± 9.9449 | 1.006 ± 3.8100 |
| Day 15: 336 hours post-dose | -0.413 ± 3.6272 | -10.640 ± 16.1897 | 1.240 ± 1.0792 | -0.050 ± 0.5766 | 0.000 ± NA | 0.900 ± 9.2772 | 0.005 ± 0.2475 | -5.550 ± 12.2071 | -1.864 ± 3.5365 | -0.133 ± 0.9903 | -2.833 ± 4.3584 | 0.713 ± 5.8229 |
| Day 36: 840 hours post-dose | 25.507 ± 44.6205 | -11.603 ± 18.4042 | 0.510 ± 0.7119 | 0.097 ± 0.3807 | — | -0.960 ± 7.2832 | 2.985 ± 2.8214 | -5.598 ± 11.5371 | 5.650 ± 12.4743 | -0.188 ± 1.5621 | -4.397 ± 7.4304 | 1.276 ± 3.1066 |
| Day 71: 1680 hours post-dose | — | — | — | — | — | — | 0.853 ± 0.2040 | -5.755 ± 12.4057 | -2.120 ± 4.0010 | 0.082 ± 1.6527 | -4.830 ± 10.8140 | 1.019 ± 0.8362 |
TNFα was one of the 3 cytokine biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1.
| ng/L | Cohort 1: PF-06755347 0.01 mg/kg IV | Cohort 2: PF-06755347 0.03 mg/kg IV | Cohort 3: PF-06755347 0.1 mg/kg IV | Cohort 4: PF-06755347 0.3 mg/kg IV | Cohort 5: PF-06755347 1 mg/kg IV | Cohort 6: PF-06755347 0.7 mg/kg IV | Cohort 7: PF-06755347 25 mg SC | Cohort 8: PF-06755347 50 mg SC | Cohort 9: PF-06755347 100 mg SC | Cohort 10: PF-06755347 200 mg SC | Cohort 11: PF-06755347 300 mg SC | Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1: 1 hour post-dose | -0.0500 ± 0.06000 | -0.0667 ± 0.31565 | 0.6533 ± 0.83032 | 4.8733 ± 3.27147 | 59.7100 ± 34.37035 | 38.5200 ± 29.69790 | -0.0250 ± 0.06051 | 0.0048 ± 0.06199 | 0.1200 ± NA | — | — | 0.0055 ± 0.11117 |
| Day 1: 3 hours post-dose | -0.1100 ± 0.21932 | 0.4567 ± 0.21939 | 10.7767 ± 10.67258 | 20.4567 ± 7.74517 | 217.9767 ± 78.32721 | 97.4267 ± 89.31240 | 0.0327 ± 0.08016 | 0.1905 ± 0.27975 | 0.3600 ± NA | — | — | 0.0198 ± 0.12203 |
| Day 1: 5 hours post-dose | -0.0833 ± 0.08505 | 0.1333 ± 0.27062 | 5.8100 ± 3.05779 | 9.0900 ± 1.62613 | 49.6433 ± 18.57913 | 15.6900 ± 4.25678 | 0.0673 ± 0.10808 | 0.5760 ± 1.36848 | 0.3422 ± 0.43494 | 10.4592 ± 16.00977 | 1.7770 ± 0.92867 | -0.1024 ± 0.08281 |
| Day 1: 8 hours post-dose | — | — | — | — | 23.8900 ± NA | 5.6750 ± 2.41123 | 0.3103 ± 0.37419 | 0.6442 ± 1.36307 | 1.7800 ± NA | — | — | -0.1326 ± 0.13676 |
| Day 1: 12 hours post-dose | — | — | — | — | 11.0900 ± NA | 2.7700 ± 1.41421 | 0.4367 ± 0.48959 | 0.4453 ± 0.65376 | 1.1792 ± 0.71557 | 1.7025 ± 0.71450 | 1.3270 ± 0.18793 | -0.1489 ± 0.13550 |
| Day 2: 24 hours post-dose | 0.2567 ± 0.06110 | 0.0567 ± 0.31501 | 1.3067 ± 0.25325 | 0.8700 ± 0.09644 | 2.8000 ± 1.25790 | 1.6150 ± 1.77484 | 0.1383 ± 0.05777 | 0.3792 ± 0.53143 | 0.9425 ± 0.50586 | 1.0875 ± 0.40787 | 0.7370 ± 0.19120 | 0.0585 ± 0.13732 |
| Day 3: 48 hours post-dose | 0.2200 ± 0.30447 | 0.0333 ± 0.21362 | 0.5967 ± 0.17559 | 0.0933 ± 0.54151 | 0.4967 ± 0.30022 | 0.7533 ± 1.52998 | 0.0883 ± 0.06213 | 0.1830 ± 0.20827 | 0.5225 ± 0.24791 | 0.5575 ± 0.24078 | 0.4237 ± 0.06199 | 0.0784 ± 0.29068 |
| Day 4: 72 hours post-dose | 0.0433 ± 0.44004 | -0.0167 ± 0.39954 | 0.2767 ± 0.32929 | -0.1467 ± 0.32470 | 0.0900 ± 0.22539 | 0.7100 ± 1.04159 | 0.0227 ± 0.12889 | 0.1182 ± 0.20360 | 0.2665 ± 0.14113 | 0.1608 ± 0.17623 | 0.3293 ± 0.11039 | 0.2039 ± 0.73037 |
| Day 5: 96 hours post-dose | — | — | — | — | — | — | — | — | 0.1820 ± 0.10060 | 0.1644 ± 0.14800 | 0.2643 ± 0.06914 | -0.0080 ± 0.10568 |
| Day 8: 168 hours post-dose | -0.1600 ± 0.38974 | -0.3633 ± 0.52205 | 0.1867 ± 0.54647 | -0.0667 ± 0.43730 | 0.0267 ± 0.31342 | 0.2233 ± 0.32130 | -0.0350 ± 0.12758 | 0.0383 ± 0.17292 | -0.0317 ± 0.17725 | 0.0098 ± 0.04696 | 0.1697 ± 0.05604 | 0.0237 ± 0.20192 |
| Day 15: 336 hours post-dose | -0.1833 ± 0.37873 | -0.4133 ± 0.56722 | 0.5033 ± 0.71501 | -0.1233 ± 0.10017 | 0.2300 ± NA | -0.5810 ± 0.96308 | 0.1685 ± 0.26092 | 0.2715 ± 0.36900 | 0.0280 ± 0.16664 | 0.0310 ± 0.12138 | 0.1297 ± 0.30426 | 0.0909 ± 0.49582 |
| Day 36: 840 hours post-dose | 0.3233 ± 0.21733 | -0.5767 ± 0.99470 | 0.4867 ± 0.96500 | 0.2633 ± 0.63129 | — | -1.2265 ± 0.15910 | 0.0650 ± 0.41154 | 0.4748 ± 0.44527 | 0.2776 ± 0.56067 | -0.1340 ± 0.19649 | -0.0040 ± 0.02330 | -0.0090 ± 0.85788 |
| Day 71: 840 hours post-dose | — | — | — | — | — | — | 0.1363 ± 0.25455 | 0.5913 ± 0.28774 | -0.0340 ± 0.25211 | -0.1698 ± 0.20600 | 0.1327 ± 0.19433 | -0.0820 ± 0.24109 |
IL-6 was one of the 3 cytokine biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1.
| ng/L | Cohort 1: PF-06755347 0.01 mg/kg IV | Cohort 2: PF-06755347 0.03 mg/kg IV | Cohort 3: PF-06755347 0.1 mg/kg IV | Cohort 4: PF-06755347 0.3 mg/kg IV | Cohort 5: PF-06755347 1 mg/kg IV | Cohort 6: PF-06755347 0.7 mg/kg IV | Cohort 7: PF-06755347 25 mg SC | Cohort 8: PF-06755347 50 mg SC | Cohort 9: PF-06755347 100 mg SC | Cohort 10: PF-06755347 200 mg SC | Cohort 11: PF-06755347 300 mg SC | Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1: 1 hour post-dose | 0.0177 ± 0.03060 | -0.0207 ± 0.08003 | 0.0743 ± 0.12009 | 0.9653 ± 1.35472 | 0.6757 ± 0.80530 | 2.1110 ± 2.86966 | 0.0000 ± 0.00000 | 0.2665 ± 0.38316 | 0.1410 ± NA | — | — | 0.0120 ± 0.07478 |
| Day 1: 3 hours post-dose | 0.7137 ± 0.53129 | 0.3280 ± 0.33207 | 4.7613 ± 5.00708 | 24.9907 ± 28.82106 | 1261.782 ± 1377.243 | 365.8777 ± 534.9345 | 0.2863 ± 0.13785 | 2.3943 ± 2.26382 | 1.1740 ± NA | — | — | 0.3684 ± 0.77453 |
| Day 1: 5 hours post-dose | 0.8893 ± 0.97631 | 0.6083 ± 0.46302 | 5.4180 ± 6.21463 | 10.7307 ± 5.75904 | 817.4487 ± 952.5663 | 16.1545 ± 9.43210 | 0.2970 ± 0.31973 | 2.8793 ± 2.33024 | 1.7130 ± 2.18458 | 53.7213 ± 107.2734 | 11.1390 ± 16.70153 | 0.2653 ± 0.48087 |
| Day 1: 8 hours post-dose | — | — | — | — | 35.2980 ± NA | 0.3100 ± 0.65620 | 0.4090 ± 0.31213 | 3.1483 ± 4.27777 | 1.7440 ± NA | — | — | 0.6368 ± 0.62657 |
| Day 1: 12 hours post-dose | — | — | — | — | 6.4480 ± NA | 0.1375 ± 0.81529 | 0.7460 ± 0.42248 | 3.3927 ± 1.80711 | 1.9242 ± 2.23190 | 1.2097 ± 0.72824 | 0.6550 ± 0.33707 | 0.3799 ± 0.63486 |
| Day 2: 24 hours post-dose | 0.0817 ± 0.14145 | 0.1917 ± 0.24744 | 0.2260 ± 0.23010 | 0.1040 ± 0.09938 | 0.8647 ± 0.93571 | -0.0495 ± 0.55084 | 0.4147 ± 0.71822 | 3.5448 ± 3.52636 | 0.2730 ± 0.29167 | 0.0957 ± 0.13221 | 1.3477 ± 2.13897 | 0.1433 ± 0.20404 |
| Day 3: 48 hours post-dose | 0.3813 ± 0.66049 | -0.0063 ± 0.04087 | 0.0927 ± 0.10203 | 0.0120 ± 0.4405 | -0.0667 ± 0.11547 | -0.0937 ± 0.30933 | 0.5713 ± 0.98958 | 0.2855 ± 0.60079 | 2.1285 ± 4.43835 | 0.0155 ± 0.03797 | 0.5043 ± 0.80624 | 0.0974 ± 0.35056 |
| Day 4: 72 hours post-dose | 0.3947 ± 0.68358 | 0.3010 ± 0.30959 | -0.0087 ± 0.01250 | 0.0960 ± 0.16628 | 0.6127 ± 1.06117 | -0.1297 ± 0.26905 | 0.1830 ± 0.16928 | 0.1143 ± 0.22064 | 0.2382 ± 0.53605 | 0.1062 ± 0.13652 | -0.0157 ± 0.02714 | 0.1368 ± 0.81459 |
| Day 5: 96 hours post-dose | — | — | — | — | — | — | — | — | 0.0834 ± 0.73122 | 1.7690 ± 3.78958 | -0.0277 ± 0.04792 | 0.0000 ± 0.0000 |
| Day 8: 168 hours post-dose | 0.0787 ± 0.13625 | -0.0310 ± 0.05369 | 0.0727 ± 0.06972 | 0.0000 ± 0.0000 | 0.0070 ± 0.23658 | -0.1203 ± 0.27872 | 0.0000 ± 0.00000 | 0.0780 ± 0.10187 | 0.0100 ± 0.81680 | 0.0284 ± 0.06350 | 0.0180 ± 0.03118 | -0.0282 ± 0.56396 |
| Day 15: 336 hours post-dose | 0.0847 ± 0.11301 | 0.1570 ± 0.27193 | 0.1563 ± 0.15264 | 2.1150 ± 3.50770 | 0.0000 ± NA | 0.5620 ± 0.79479 | 0.0000 ± 0.0000 | 0.0298 ± 0.08751 | -0.0998 ± 0.40069 | 0.0000 ± 0.0000 | 0.2797 ± 0.48440 | -0.0737 ± 0.43828 |
| Day 36: 840 hours post-dose | 0.7927 ± 1.36082 | -0.0247 ± 0.04272 | 0.3590 ± 0.27029 | 0.0340 ± 0.05889 | — | 0.0000 ± 0.0000 | 0.0105 ± 0.01485 | -0.0047 ± 0.01143 | 0.1396 ± 0.23005 | 0.0774 ± 0.17307 | 0.0710 ± 0.12298 | 0.0861 ± 0.15271 |
| Day 71: 1680 hours post-dose | — | — | — | — | — | — | 0.0000 ± 0.0000 | 0.0255 ± 0.07700 | -0.0758 ± 0.61407 | 0.0000 ± 0.0000 | 0.2030 ± 0.35161 | 0.0539 ± 0.16145 |
C3a was one of the 3 complement components/biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1.
| micrograms per liter (mcg/L) | Cohort 1: PF-06755347 0.01 mg/kg IV | Cohort 2: PF-06755347 0.03 mg/kg IV | Cohort 3: PF-06755347 0.1 mg/kg IV | Cohort 4: PF-06755347 0.3 mg/kg IV | Cohort 5: PF-06755347 1 mg/kg IV | Cohort 6: PF-06755347 0.7 mg/kg IV | Cohort 7: PF-06755347 25 mg SC | Cohort 8: PF-06755347 50 mg SC | Cohort 9: PF-06755347 100 mg SC | Cohort 10: PF-06755347 200 mg SC | Cohort 11: PF-06755347 300 mg SC | Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1: 1 hour post-dose | 2234.0 ± 2663.07 | 0.0 ± 0.00 | 1570.0 ± 795.05 | 730.0 ± 1889.87 | 2680.7 ± 2327.03 | 4310.0 ± 3997.14 | 260.0 ± 450.33 | 131.8 ± 317.57 | 0.0 ± NA | — | — | -425.1 ± 779.62 |
| Day 1: 3 hours post-dose | 0.0 ± 0.00 | 0.0 ± 0.00 | -133.3 ± 675.45 | -827.0 ± 1293.35 | 1017.0 ± 1761.50 | 360.0 ± 2941.56 | -13.3 ± 23.09 | 1138.7 ± 2152.68 | 0.0 ± NA | — | — | -364.0 ± 937.82 |
| Day 1: 5 hours post-dose | 0.0 ± 0.00 | 0.0 ± 0.00 | 1219.7 ± 2513.81 | -1214.0 ± 1129.48 | 33.7 ± 58.31 | -115.5 ± 3741.30 | 13.3 ± 23.09 | 188.5 ± 296.99 | 1348.5 ± 1359.62 | -170.2 ± 796.82 | 1093.7 ± 1681.60 | -162.0 ± 767.87 |
| Day 1: 8 hours post-dose | — | — | — | — | 0.0 ± NA | -430.5 ± 3295.82 | -70.0 ± 121.24 | 541.8 ± 844.36 | 0.0 ± NA | — | — | -176.0 ± 393.55 |
| Day 1: 12 hours post-dose | — | — | — | — | 0.0 ± NA | 1650.0 ± 3691.10 | -173.7 ± 300.80 | 705.2 ± 1132.91 | 518.3 ± 752.66 | -583.5 ± 1326.10 | 440.0 ± 762.10 | 569.3 ± 1040.58 |
| Day 2: 24 hours post-dose | 0.0 ± 0.00 | 33.7 ± 58.31 | 3626.3 ± 4819.80 | -1394.0 ± 1422.73 | 507.0 ± 878.15 | -1425.5 ± 1888.68 | 526.7 ± 1388.08 | 588.5 ± 1225.78 | 383.3 ± 890.52 | -548.5 ± 1846.32 | -76.7 ± 132.79 | -187.4 ± 1055.28 |
| Day 3: 48 hours post-dose | 0.0 ± 0.00 | 10.3 ± 17.90 | 516.7 ± 1030.55 | -937.3 ± 2577.06 | 737.0 ± 1276.52 | -333.7 ± 1803.48 | -173.7 ± 300.80 | 210.2 ± 711.62 | 1418.5 ± 2194.12 | -640.5 ± 1839.01 | 330.0 ± 571.58 | 174.3 ± 1669.50 |
| Day 4: 72 hours post-dose | 83.7 ± 144.9 | 80.3 ± 139.14 | -170.0 ± 810.19 | -1561.0 ± 1700.71 | 0.0 ± 0.00 | -757.0 ± 1336.62 | -53.3 ± 92.38 | 65.0 ± 581.79 | 295.2 ± 739.73 | -1133.7 ± 1614.09 | 710.0 ± 1229.76 | -77.6 ± 766.58 |
| Day 5: 96 hours post-dose | — | — | — | — | — | — | — | — | 475.8 ± 777.97 | -252.2 ± 2190.36 | -346.7 ± 600.44 | 788.2 ± 2632.47 |
| Day 8: 168 hours post-dose | 407.0 ± 704.94 | 0.0 ± 0.00 | -240.7 ± 1064.66 | -1120.7 ± 2039.85 | 403.7 ± 699.17 | -407.0 ± 2048.41 | -173.7 ± 300.80 | 530.2 ± 822.22 | 876.7 ± 993.91 | -1078.2 ± 1941.86 | 383.3 ± 663.95 | 262.4 ± 1096.43 |
| Day 15: 336 hours post-dose | 0.0 ± 0.00 | 0.0 ± 0.00 | 519.7 ± 2234.46 | -780.3 ± 594.56 | 0.0 ± NA | 129.5 ± 1075.51 | -260.5 ± 368.40 | 1410.5 ± 2078.58 | -536.4 ± 602.28 | -688.0 ± 2313.92 | 693.3 ± 1200.89 | -70.7 ± 1343.24 |
| Day 36: 840 hours post-dose | 1727.3 ± 1545.92 | 0.0 ± 0.00 | 1960.0 ± 2817.68 | -1561.0 ± 1700.71 | — | -656.0 ± 35.36 | -260.5 ± 368.40 | 567.2 ± 729.62 | 1062.2 ± 2324.85 | -1298.4 ± 1672.16 | 693.3 ± 1200.89 | 470.0 ± 3018.14 |
| Day 71: 1680 hours post-dose | — | — | — | — | — | — | 1713.3 ± 3428.69 | 1830.8 ± 1654.01 | 2330.3 ± 3100.19 | -1734.6 ± 1602.72 | 156.7 ± 271.35 | 436.1 ± 1343.41 |
C5a was one of the 3 complement components/biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1.
| mcg/L | Cohort 1: PF-06755347 0.01 mg/kg IV | Cohort 2: PF-06755347 0.03 mg/kg IV | Cohort 3: PF-06755347 0.1 mg/kg IV | Cohort 4: PF-06755347 0.3 mg/kg IV | Cohort 5: PF-06755347 1 mg/kg IV | Cohort 6: PF-06755347 0.7 mg/kg IV | Cohort 7: PF-06755347 25 mg SC | Cohort 8: PF-06755347 50 mg SC | Cohort 9: PF-06755347 100 mg SC | Cohort 10: PF-06755347 200 mg SC | Cohort 11: PF-06755347 300 mg SC | Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1: 1 hour post-dose | 0.623 ± 0.4709 | -0.167 ± 1.6862 | 0.213 ± 0.2676 | -0.283 ± 0.6417 | -0.627 ± 0.2098 | -0.613 ± 0.0643 | 0.083 ± 0.1193 | -0.283 ± 0.6940 | 5.300 ± NA | — | — | -0.183 ± 0.8073 |
| Day 1: 3 hours post-dose | 0.870 ± 0.2343 | -0.057 ± 0.9869 | -0.040 ± 0.2862 | -0.983 ± 0.7184 | -0.827 ± 0.4311 | -0.655 ± 0.0071 | 0.023 ± 0.0681 | -0.153 ± 0.4864 | 11.300 ± NA | — | — | -0.219 ± 1.3316 |
| Day 1: 5 hours post-dose | -0.027 ± 0.0379 | 4.413 ± 9.3654 | -0.067 ± 0.3150 | -1.140 ± 1.2813 | -0.317 ± 0.3281 | -0.485 ± 0.2475 | 0.127 ± 0.1115 | -0.183 ± 0.4491 | 4.102 ± 6.1943 | -0.177 ± 0.7212 | 0.410 ± 0.3996 | -0.176 ± 1.0820 |
| Day 1: 8 hours post-dose | — | — | — | — | 0.710 ± NA | -0.445 ± 0.3041 | 0.013 ± 0.0231 | -0.275 ± 0.7237 | 7.700 ± NA | — | — | -0.130 ± 0.4181 |
| Day 1: 12 hours post-dose | — | — | — | — | -0.680 ± NA | -0.605 ± 0.0778 | 0.210 ± 0.3637 | -0.220 ± 0.7804 | -4.413 ± 6.3713 | 0.035 ± 0.7219 | 0.043 ± 0.4466 | -0.044 ± 0.6347 |
| Day 2: 24 hours post-dose | 0.907 ± 0.6881 | 0.730 ± 2.6751 | 0.003 ± 0.6153 | 2.713 ± 4.5502 | 3.717 ± 3.8882 | -0.670 ± 0.0141 | 0.190 ± 0.3291 | -0.233 ± 0.7781 | 0.767 ± 9.8244 | 0.425 ± 0.8435 | -0.380 ± 0.5027 | -0.015 ± 0.5437 |
| Day 3: 48 hours post-dose | 0.987 ± 0.9901 | 1.077 ± 3.6656 | 0.360 ± 0.4004 | 0.833 ± 3.0087 | 2.043 ± 2.4110 | -0.403 ± 0.3194 | 0.197 ± 0.3406 | -0.062 ± 0.8170 | -0.142 ± 8.3021 | -0.235 ± 0.6678 | -0.143 ± 0.2658 | 0.312 ± 0.5937 |
| Day 4: 72 hours post-dose | 0.290 ± 1.3130 | 3.907 ± 6.9842 | -0.107 ± 0.5805 | 0.257 ± 1.7737 | 1.617 ± 0.8663 | -0.423 ± 0.3927 | 0.163 ± 0.2829 | -0.282 ± 0.7349 | -0.327 ± 9.5142 | -0.383 ± 0.9286 | 0.473 ± 0.9347 | 0.398 ± 1.5906 |
| Day 5: 96 hours post-dose | — | — | — | — | — | — | — | — | 10.166 ± 15.4306 | -0.452 ± 0.7897 | -0.293 ± 0.6240 | -0.307 ± 0.4571 |
| Day 8: 168 hours post-dose | 3.230 ± 6.0836 | -1.280 ± 1.1086 | -0.323 ± 0.7149 | -0.667 ± 0.7332 | 0.330 ± 0.1015 | -0.643 ± 0.0153 | 0.027 ± 0.0462 | 0.217 ± 0.3525 | 13.542 ± 20.3702 | -0.284 ± 0.4548 | -0.150 ± 0.6874 | 0.001 ± 1.7010 |
| Day 15: 336 hours post-dose | 2.023 ± 1.8553 | 2.310 ± 4.7039 | -0.287 ± 0.7174 | -0.067 ± 1.1829 | 0.930 ± NA | -0.550 ± 0.1273 | 0.000 ± 0.0000 | 2.898 ± 7.8222 | -11.698 ± 14.0227 | -0.703 ± 1.9050 | 0.257 ± 1.0000 | 0.081 ± 1.1008 |
| Day 36: 840 hours post-dose | 2.077 ± 1.8309 | -1.083 ± 1.1453 | -0.113 ± 0.2747 | -0.657 ± 1.7796 | — | -0.660 ± 0.0283 | -0.085 ± 0.1202 | 2.277 ± 6.9301 | -10.962 ± 14.6454 | -0.456 ± 0.8780 | -0.283 ± 0.5346 | 0.464 ± 1.5409 |
| Day 71: 1680 hours post-dose | — | — | — | — | — | — | 0.580 ± 1.1549 | 10.358 ± 18.0554 | -9.218 ± 13.7046 | 0.080 ± 1.3326 | -0.310 ± 0.5112 | 1.984 ± 4.3754 |
Bb was one of the complement components/biomarkers explored in the study. Baseline was defined as the average of measurement on Day -1 and pre-dose (0 hours) measurement on Day 1.
| milligrams per liter (mg/L) | Cohort 1: PF-06755347 0.01 mg/kg IV | Cohort 2: PF-06755347 0.03 mg/kg IV | Cohort 3: PF-06755347 0.1 mg/kg IV | Cohort 4: PF-06755347 0.3 mg/kg IV | Cohort 5: PF-06755347 1 mg/kg IV | Cohort 6: PF-06755347 0.7 mg/kg IV | Cohort 7: PF-06755347 25 mg SC | Cohort 8: PF-06755347 50 mg SC | Cohort 9: PF-06755347 100 mg SC | Cohort 10: PF-06755347 200 mg SC | Cohort 11: PF-06755347 300 mg SC | Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Day 1: 1 hour post-dose | 0.277 ± 0.2574 | 0.177 ± 0.1106 | 0.680 ± 0.1735 | 1.897 ± 1.4677 | 3.713 ± 1.2371 | 4.130 ± 0.4888 | -0.073 ± 0.1563 | -0.518 ± 1.1527 | 0.000 ± NA | — | — | 0.132 ± 0.2589 |
| Day 1: 3 hours post-dose | 0.057 ± 0.3636 | 0.253 ± 0.0473 | 0.593 ± 0.1943 | 0.977 ± 0.9903 | 3.920 ± 1.6404 | 2.850 ± 0.1838 | 0.117 ± 0.2011 | -0.015 ± 0.7729 | 0.120 ± NA | — | — | 0.175 ± 0.3925 |
| Day 1: 5 hours post-dose | -0.117 ± 0.3980 | -0.243 ± 0.3557 | 0.117 ± 0.1150 | 0.260 ± 0.2762 | 2.313 ± 2.3526 | 1.355 ± 0.0636 | 0.163 ± 0.1626 | -0.253 ± 1.4442 | 0.048 ± 0.0560 | 1.013 ± 0.8021 | 0.673 ± 0.5974 | 0.031 ± 0.2548 |
| Day 1: 8 hours post-dose | — | — | — | — | 1.670 ± NA | 0.375 ± 0.3889 | 0.067 ± 0.3308 | -0.432 ± 1.5607 | 0.240 ± NA | — | — | 0.030 ± 0.2307 |
| Day 1: 12 hours post-dose | — | — | — | — | 0.830 ± NA | 0.145 ± 0.2051 | 0.097 ± 0.5154 | -0.318 ± 1.8083 | 0.198 ± 0.1277 | 0.775 ± 0.5881 | 0.523 ± 0.5636 | -0.015 ± 0.2355 |
| Day 2: 24 hours post-dose | -0.360 ± 0.1637 | -0.097 ± 0.3465 | -0.233 ± 0.4041 | -0.577 ± 1.0866 | 0.377 ± 0.5680 | 0.315 ± 0.4455 | 0.030 ± 0.5565 | -0.322 ± 1.6140 | 0.220 ± 0.2082 | 0.908 ± 1.2157 | 0.413 ± 0.3602 | -0.016 ± 0.4309 |
| Day 3: 48 hours post-dose | -0.273 ± 0.0802 | -0.230 ± 0.3974 | 0.023 ± 0.0252 | -0.617 ± 1.1825 | 0.257 ± 0.4532 | 0.320 ± 0.5632 | 0.127 ± 0.6966 | 0.090 ± 1.5773 | 0.255 ± 0.2673 | 0.312 ± 0.5293 | 0.203 ± 0.2050 | 0.156 ± 0.7536 |
| Day 4: 72 hours post-dose | -0.133 ± 0.3057 | 0.437 ± 0.2318 | -0.127 ± 0.2194 | -0.640 ± 1.1521 | 0.153 ± 0.8702 | 0.100 ± 0.3219 | 0.100 ± 0.3260 | 0.082 ± 0.4979 | 0.335 ± 0.2649 | 0.250 ± 0.3824 | 0.160 ± 0.1600 | 0.196 ± 0.5920 |
| Day 5: 96 hours post-dose | — | — | — | — | — | — | — | — | 0.372 ± 0.4206 | -0.016 ± 0.5003 | 0.053 ± 0.0462 | -0.018 ± 0.7665 |
| Day 8: 168 hours post-dose | -0.423 ± 0.0961 | -0.217 ± 0.3121 | -0.067 ± 0.1155 | -0.657 ± 1.0185 | 0.110 ± 0.3772 | 0.083 ± 0.2940 | -0.050 ± 0.2787 | -0.047 ± 0.7904 | 0.158 ± 0.3306 | -0.522 ± 0.5220 | 0.057 ± 0.0981 | 0.187 ± 0.5747 |
| Day 15: 336 hours post-dose | -0.020 ± 0.5429 | -0.100 ± 0.4911 | -0.157 ± 0.2714 | -0.820 ± 1.3516 | -0.280 ± NA | -0.025 ± 0.0354 | -0.090 ± 0.0707 | -0.377 ± 1.4630 | 0.126 ± 0.2881 | -0.445 ± 0.6457 | 0.583 ± 1.0104 | 0.137 ± 0.4811 |
| Day 36: 840 hours post-dose | -0.250 ± 0.2951 | -0.387 ± 0.4382 | -0.107 ± 0.3235 | -0.700 ± 1.0522 | — | 0.360 ± 0.4525 | 0.450 ± 0.9617 | -1.018 ± 1.6763 | 0.890 ± 1.0579 | -0.040 ± 0.2539 | 0.163 ± 0.2329 | 0.266 ± 0.4960 |
| Day 71: 1680 hours post-dose | — | — | — | — | — | — | 2.067 ± 2.8386 | -1.165 ± 2.2748 | 0.818 ± 0.5851 | -0.466 ± 0.4039 | 0.193 ± 0.3349 | 0.058 ± 0.5159 |
Collected over Baseline (Study Day -2) through study completion (Study Day 36 for IV treatment cohorts, and Study Day 71 SC treatment cohorts).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1: PF-06755347 0.01 mg/kg IV | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Cohort 2: PF-06755347 0.03 mg/kg IV | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) |
| Cohort 3: PF-06755347 0.1 mg/kg IV | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Cohort 4: PF-06755347 0.3 mg/kg IV | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Cohort 5: PF-06755347 1 mg/kg IV | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Cohort 6: PF-06755347 0.7 mg/kg IV | 0/3 (0%) | 1/3 (33.3%) | 2/3 (66.7%) |
| Cohort 7: PF-06755347 25 mg SC | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Cohort 8: PF-06755347 50 mg SC | 0/6 (0%) | 0/6 (0%) | 6/6 (100%) |
| Cohort 9: PF-06755347 100 mg SC | 0/6 (0%) | 0/6 (0%) | 6/6 (100%) |
| Cohort 10: PF-06755347 200 mg SC | 0/6 (0%) | 0/6 (0%) | 5/6 (83.3%) |
| Cohort 11: PF-06755347 300 mg SC | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Placebo | 0/16 (0%) | 0/16 (0%) | 10/16 (62.5%) |
| Event | Cohort 1: PF-06755347 0.01 mg/kg IV | Cohort 2: PF-06755347 0.03 mg/kg IV | Cohort 3: PF-06755347 0.1 mg/kg IV | Cohort 4: PF-06755347 0.3 mg/kg IV | Cohort 5: PF-06755347 1 mg/kg IV | Cohort 6: PF-06755347 0.7 mg/kg IV | Cohort 7: PF-06755347 25 mg SC | Cohort 8: PF-06755347 50 mg SC | Cohort 9: PF-06755347 100 mg SC | Cohort 10: PF-06755347 200 mg SC | Cohort 11: PF-06755347 300 mg SC | Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cytokine release syndromeImmune system disorders | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 1/3 | 0/3 | 0/6 | 0/6 | 0/6 | 0/3 | 0/16 |
| Event | Cohort 1: PF-06755347 0.01 mg/kg IV | Cohort 2: PF-06755347 0.03 mg/kg IV | Cohort 3: PF-06755347 0.1 mg/kg IV | Cohort 4: PF-06755347 0.3 mg/kg IV | Cohort 5: PF-06755347 1 mg/kg IV | Cohort 6: PF-06755347 0.7 mg/kg IV | Cohort 7: PF-06755347 25 mg SC | Cohort 8: PF-06755347 50 mg SC | Cohort 9: PF-06755347 100 mg SC | Cohort 10: PF-06755347 200 mg SC | Cohort 11: PF-06755347 300 mg SC | Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NauseaGastrointestinal disorders | 0/3 | 0/3 | 0/3 | 1/3 | 3/3 | 0/3 | 0/3 | 0/6 | 0/6 | 0/6 | 0/3 | 0/16 |
| Injection site erythemaGeneral disorders | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 2/3 | 0/6 | 5/6 | 2/6 | 2/3 | 0/16 |
| Feeling coldGeneral disorders | 0/3 | 0/3 | 1/3 | 0/3 | 2/3 | 0/3 | 0/3 | 1/6 | 0/6 | 1/6 | 0/3 | 0/16 |
| Vessel puncture site haematomaGeneral disorders | 0/3 | 0/3 | 2/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/6 | 1/6 | 0/6 | 0/3 | 1/16 |
| Cytokine release syndromeImmune system disorders | 0/3 | 0/3 | 0/3 | 0/3 | 2/3 | 1/3 | 0/3 | 1/6 | 0/6 | 0/6 | 1/3 | 0/16 |
| HeadacheNervous system disorders | 1/3 | 0/3 | 1/3 | 1/3 | 2/3 | 1/3 | 0/3 | 0/6 | 1/6 | 2/6 | 1/3 | 0/16 |
| Sinus tachycardiaCardiac disorders | 0/3 | 0/3 | 0/3 | 0/3 | 1/3 | 0/3 | 0/3 | 0/6 | 0/6 | 0/6 | 0/3 | 0/16 |
| Dry eyeEye disorders | 0/3 | 0/3 | 1/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/6 | 0/6 | 0/6 | 0/3 | 0/16 |
| Abdominal discomfortGastrointestinal disorders | 0/3 | 1/3 | 0/3 | 0/3 | 0/3 | 0/3 | 1/3 | 0/6 | 0/6 | 0/6 | 0/3 | 0/16 |
| Aphthous ulcerGastrointestinal disorders | 0/3 | 1/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/6 | 0/6 | 0/6 | 0/3 | 0/16 |
| Age, Customized(Participants) | Cohort 1: PF-06755347 0.01 mg/kg IV | Cohort 2: PF-06755347 0.03 mg/kg IV | Cohort 3: PF-06755347 0.1 mg/kg IV | Cohort 4: PF-06755347 0.3 mg/kg IV | Cohort 5: PF-06755347 1 mg/kg IV | Cohort 6: PF-06755347 0.7 mg/kg IV | Cohort 7: PF-06755347 25 mg SC | Cohort 8: PF-06755347 50 mg SC | Cohort 9: PF-06755347 100 mg SC | Cohort 10: PF-06755347 200 mg SC | Cohort 11: PF-06755347 300 mg SC | Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 18-25 years | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 2 | 0 | 4 | 15 |
| 26-35 years | 1 | 1 | 0 | 0 | 2 | 1 | 1 | 1 | 0 | 2 | 3 | 5 | 17 |
| 36-45 years | 1 | 1 | 2 | 2 | 0 | 0 | 0 | 2 | 2 | 2 | 0 | 2 | 14 |
| 46-55 years | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 2 | 3 | 0 | 0 | 5 | 12 |
| Sex: Female, Male(Participants) | Cohort 1: PF-06755347 0.01 mg/kg IV | Cohort 2: PF-06755347 0.03 mg/kg IV | Cohort 3: PF-06755347 0.1 mg/kg IV | Cohort 4: PF-06755347 0.3 mg/kg IV | Cohort 5: PF-06755347 1 mg/kg IV | Cohort 6: PF-06755347 0.7 mg/kg IV | Cohort 7: PF-06755347 25 mg SC | Cohort 8: PF-06755347 50 mg SC | Cohort 9: PF-06755347 100 mg SC | Cohort 10: PF-06755347 200 mg SC | Cohort 11: PF-06755347 300 mg SC | Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Male | 3 | 3 | 3 | 3 | 3 | 3 | 3 | 6 | 6 | 6 | 3 | 16 | 58 |
| Race/Ethnicity, Customized(Participants) | Cohort 1: PF-06755347 0.01 mg/kg IV | Cohort 2: PF-06755347 0.03 mg/kg IV | Cohort 3: PF-06755347 0.1 mg/kg IV | Cohort 4: PF-06755347 0.3 mg/kg IV | Cohort 5: PF-06755347 1 mg/kg IV | Cohort 6: PF-06755347 0.7 mg/kg IV | Cohort 7: PF-06755347 25 mg SC | Cohort 8: PF-06755347 50 mg SC | Cohort 9: PF-06755347 100 mg SC | Cohort 10: PF-06755347 200 mg SC | Cohort 11: PF-06755347 300 mg SC | Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Race — White | 3 | 2 | 3 | 3 | 3 | 3 | 3 | 5 | 6 | 4 | 3 | 16 | 54 |
| Race — Black or African American | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 |
| Race — Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 2 |
| Race/Ethnicity, Customized(Participants) | Cohort 1: PF-06755347 0.01 mg/kg IV | Cohort 2: PF-06755347 0.03 mg/kg IV | Cohort 3: PF-06755347 0.1 mg/kg IV | Cohort 4: PF-06755347 0.3 mg/kg IV | Cohort 5: PF-06755347 1 mg/kg IV | Cohort 6: PF-06755347 0.7 mg/kg IV | Cohort 7: PF-06755347 25 mg SC | Cohort 8: PF-06755347 50 mg SC | Cohort 9: PF-06755347 100 mg SC | Cohort 10: PF-06755347 200 mg SC | Cohort 11: PF-06755347 300 mg SC | Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ethnicity — Not Hispanic or Latino | 3 | 3 | 3 | 2 | 2 | 3 | 3 | 5 | 5 | 6 | 3 | 14 | 52 |
| Ethnicity — Hispanic or Latino | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 2 | 6 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Ran from Jul 2017 to primary completion in Jan 2023, 65 months.
Results were first posted in Jul 2024, 1 year 5 months after primary completion.
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Purpura, Thrombocytopenic, Idiopathic →