A Phase 2 interventional study of AB023- Dose 1 and AB023-Dose 2 in End Stage Renal Disease and Thrombosis, sponsored by Aronora, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-07.
Sponsored by Aronora, Inc. · Phase 2, Interventional, and Prevention
This study evaluates the safety and efficacy of AB023 (xisomab 3G3) in patients with end stage renal disease on chronic hemodialysis. Two dose levels will be evaluated in two cohorts. Within each cohort the patients will be randomized to receive either AB023 (xisomab 3G3) or placebo (at a ratio of 2:1 active: placebo).
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's enrollment of 27 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Aronora, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients must fulfill all of the following inclusion criteria to be eligible for participation in the study:
Female patients must be of non- and must have undergone one of the following:
Exclusion Criteria:
Patients must not be enrolled in the study if they meet any of the following criteria:
Pregnant (positive pregnancy test) at screening or check-in on Day -8. If serum human chorionic gonadotropin (hCG) pregnancy test results are indeterminate, follow-up testing should be performed to determine eligibility.
All female patients will not be pregnant and will have a negative pregnancy test at screening and check-in on Day -8, with the following exception: females receiving dialysis with an indeterminate pregnancy test result or persistently low hCG resulting in a false positive pregnancy test may be included in the study at the discretion of the PI. patients with a result outside the postmenopausal range or an indeterminate pregnancy test will undergo additional testing with FSH to confirm postmenopausal status prior to study enrollment.
Currently have established underlying inherited or acquired symptomatic bleeding disorders and/or are at risk for excessive bleeding per PI judgment or current active bleeding (e.g., gastrointestinal, intracranial), aside from minor bleeding from the puncture site on the AV fistula or AV graft, which would be expected to occur during the dialysis procedure, with the following values:
Exclusion criteria for at screening and check-in on Day -8:
Heart rate \< 45 and > 110 bpm interval > 500 msec (bpm = beats per minute; msec = milliseconds; QTcF = QT interval corrected using Fridericia's formula)
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.
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.
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.
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.
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
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 drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
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).
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
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.
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.
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.
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.
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.
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.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
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.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
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.
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.
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.
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3.
Drug: AB023- Dose 1
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3.
Drug: AB023-Dose 2
Participants will receive a single dose of placebo.
Drug: placebo
Participants will receive a single dose of 0.25 mg/kg AB023.
Also known as: xisomab 3G3- Dose 1
Participants will receive a single dose of 0.5 mg/kg AB023.
Also known as: xisomab 3G3- Dose 2
Participants will receive a single dose of placebo.
The Number of Subjects With Treatment-related Adverse Events (TEAEs) and the Number of TEAEs Will be Summarized Using Frequency Counts (Safety and Tolerability)
TEAEs will be determined by physical examination that will include assessment of skin, head, ears, eyes, nose, throat, respiratory system, cardiovascular system, gastrointestinal system, neurological condition, blood and lymphatic systems, and the musculoskeletal system.
Time frame: 21 days
Incidence of Bleeding at the HD Vascular Access Site (Safety and Tolerability)
The number of clinically relevant and non-major bleeding events from the vascular access site. Bleeding from the access site was assessed immediately following decannulation. Pressure was placed on the access site for 10 min. After 10 minutes, the access site was checked for bleeding. If still bleeding, pressure was applied for another 5 minutes and checked again. This was repeated until hemostasis was achieved and the time to hemostasis was recorded. A time greater than 10 min was considered a non-major bleeding event.
Time frame: Study Days -7, -5, -3 (pre-dose) 1, 3, and 5 (post-dose)
The Number of Subjects With Abnormal Electrocardiogram That is Related to Treatment Will be Summarized Using Frequency Counts (Safety and Tolerability).
12-lead electrocardiogram measurement. Abnormal electrocardiogram was determined by the study PI. The result was determined to be treatment-related if the abnormal electrocardiogram occurred post-treatment and not pre-treatment. Data from the specified time points (Study Days 6 and 12) were combined by adding the number of participants on each Study Day that showed an abnormal electrocardiogram compared to pre-treatment (Study Day -8 and Study Day 1, pre-dose).
Time frame: Study Days -8 and 1, pre-dose (pre-treatment) and Study Days 6 and 12 (post-treatment)
The Number of Subjects That Develop Treatment-related Immunogenicity Will be Summarized Using Frequency Counts (Safety and Tolerability).
Immunogenicity measured by the presence of plasma anti-drug antibodies. Plasma anti-drug antibodies were determined by a validated enzyme-linked immunosorbant assay (ELISA) and the titer of anti-drug antibodies present in patient plasma on Study day 12 was compared to the titer of anti-drug antibodies compared to Study day 1, predose.
Time frame: Study day 1 (predose) and Study Day 12
The Number of Subjects With Clinically Significant Changes in Body Temperature, Frequency, and Relation to Treatment Will be Assessed.
Body temperature will be measured in degrees Celsius. Clinically significant changes in body temperature were determined by the study PI. The result was determined to be treatment related if the change in body temperature occurred at any time post-treatment and not pre-treatment.
Time frame: Study days -7, -5, -3, and 1 (pre-treatment) and study days 1 (1h post-dose), 3, 5, 6, 8, 10, and 12 (post-treatment).
The Number of Subjects With Clinically Significant Changes in Respiratory Rate, Frequency, and Relation to Treatment Will be Assessed.
Respiratory rate will be measured in breaths per minute. Clinically significant changes in respiratory rate were determined by the study PI. The result was determined to be treatment related if the clinically significant changes in respiratory rate occurred post-treatment compared to pre-treatment.
Time frame: Study days -7, -5, -3, and 1 (pre-treatment) and study days 1 (1h post-dose), 3, 5, 6, 8, 10, and 12 (post-treatment).
The Number of Subjects With Clinically Significant Changes in Blood Pressure (Systolic and Diastolic), Frequency, and Relation to Treatment Will be Assessed.
Systolic and diastolic blood pressure will be measured in mmHg. Clinically significant changes in blood pressure were determined by the study PI. The result was determined to be treatment related if the clinically significant changes in blood pressure occurred post-treatment compared to pre-treatment.
Time frame: Study days -7, -5, -3, and 1 (pre-treatment) and study days 1 (1h post-dose), 3, 5, 6, 8, 10, and 12 (post-treatment).
The Number of Subjects With Clinically Significant Changes in Heart Rate, Frequency, and Relation to Treatment Will be Assessed.
Heart rate will be measured in beats per minute. Clinically significant changes in heart rate were determined by the study PI. The result was determined to be treatment related if the clinically significant changes in heart rate occurred post-treatment compared to pre-treatment.
Time frame: Study days -7, -5, -3, and 1 (pre-treatment) and study days 1 (1h post-dose), 3, 5, 6, 8, 10, and 12 (post-treatment).
The Number of Subjects With Clinically Significant Changes in Activated Partial Thromboplastin Time (aPTT), Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Coagulation Panel.
Plasma aPTT will be measured in seconds. Clinically significant changes in aPTT were determined by the study PI. The result was determined to be treatment related if the clinically significant changes in aPTT occurred post-treatment compared to pre-treatment.
Time frame: Study days -7, -5, -3, and 1 (pre-treatment) and study days 1 (3h post-dose), 3, 5, 6, and 12 (post-treatment).
The Number of Subjects With Clinically Significant Changes in Prothrombin Time, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Coagulation Panel.
Prothrombin time will be measured in seconds. Clinically significant changes in prothrombin time were determined by the study PI. The result was determined to be treatment related if the clinically significant changes in prothrombin time occurred post-treatment compared to pre-treatment.
Time frame: Study days -7, -5, -3, and 1 (pre-treatment) and study days 1 (3h post-dose), 3, 5, 6, and 12 (post-treatment).
The Number of Subjects With Clinically Significant Changes in Bilirubin (Total and Direct) Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.
Bilirubin (total and direct) levels in the blood will be measured in mg/dL. Clinically significant changes in bilirubin were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in bilirubin occurred post-treatment compared to pre-treatment.
Time frame: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)
The Number of Subjects With Clinically Significant Changes in Alkaline Phosphatase Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.
Alkaline phosphatase levels in the blood will be measured in U/L. Clinically significant changes in alkaline phosphatase were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in alkaline phosphatase occurred post-treatment compared to pre-treatment.
Time frame: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)
The Number of Subjects With Clinically Significant Changes in Aspartate Aminotransferase (AST) Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.
AST levels in the blood will be measured in U/L. Clinically significant changes in aspartate aminotransferase (AST) were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in AST occurred post-treatment compared to pre-treatment.
Time frame: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)
The Number of Subjects With Clinically Significant Changes in Alanine Aminotransferase (ALT) Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.
ALT levels in the blood will be measured in U/L. Clinically significant changes in alanine aminotransferase (ALT) were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in ALT occurred post-treatment compared to pre-treatment.
Time frame: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)
The Number of Subjects With Clinically Significant Changes in Lactate Dehydrogenase (LDH) Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.
LDH levels in the blood will be measured in U/L. Clinically significant changes in lactate dehydrogenase (LDH) were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in LDH occurred post-treatment compared to pre-treatment.
Time frame: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)
The Number of Subjects With Clinically Significant Changes in Albumin Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.
Albumin levels in the blood will be measured in g/dL. Clinically significant changes in albumin were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in albumin occurred post-treatment compared to pre-treatment.
Time frame: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)
The Number of Subjects With Clinically Significant Changes in Sodium Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.
Sodium levels will be measured in mEq/L. Clinically significant changes in sodium levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in sodium levels occurred post-treatment compared to pre-treatment.
Time frame: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)
The Number of Subjects With Clinically Significant Changes in Potassium Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.
Potassium levels will be measured in mEq/L. Clinically significant changes in potassium levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in potassium levels occurred post-treatment compared to pre-treatment.
Time frame: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)
The Number of Subjects With Clinically Significant Changes in Chloride Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.
Chloride levels will be measured in mEq/L. Clinically significant changes in chloride levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in chloride levels occurred post-treatment compared to pre-treatment.
Time frame: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)
The Number of Subjects With Clinically Significant Changes in Glucose Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.
Blood glucose levels will be measured in mg/dL. Clinically significant changes in glucose levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in glucose occurred post-treatment compared to pre-treatment.
Time frame: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)
The Number of Subjects With Clinically Significant Changes in Creatinine Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel.
Creatinine levels will be measured in mg/dL. Clinically significant changes in creatinine levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in creatinine levels occurred post-treatment compared to pre-treatment.
Time frame: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)
The Number of Subjects With Clinically Significant Changes in Hemoglobin Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Hematology Panel.
Hemoglobin levels will be measured in g/dL. Clinically significant changes in hemoglobin were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in hemoglobin occurred post-treatment compared to pre-treatment.
Time frame: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)
The Number of Subjects With Clinically Significant Changes in Hematocrit Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Hematology Panel.
Hematocrit levels will be measured in %. Clinically significant changes in hematocrit were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in hematocrit occurred post-treatment compared to pre-treatment.
Time frame: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)
The Number of Subjects With Clinically Significant Changes in Total Leukocyte Counts, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Hematology Panel.
Total leukocyte counts will be measured in 10˄3/uL. Clinically significant changes in total leukocyte count were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in total leukocyte count occurred post-treatment compared to pre-treatment.
Time frame: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)
The Number of Subjects With Clinically Significant Changes in Differential Leukocyte Counts, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Hematology Panel.
Differential leukocyte counts will be measured in %. Clinically significant changes in differential leukocyte counts were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in differential leukocyte counts occurred post-treatment compared to pre-treatment.
Time frame: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)
The Number of Subjects With Clinically Significant Changes in Red Blood Cell Count, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Hematology Panel.
Red blood cell count will be measured in 10˄6/uL. Clinically significant changes in red blood cell counts were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in red blood cell counts occurred post-treatment compared to pre-treatment.
Time frame: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)
The Number of Subjects With Clinically Significant Changes in Platelet Count, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Hematology Panel.
Platelet count will be measured in 10˄3/uL. Clinically significant changes in platelet count were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in platelet count occurred post-treatment compared to pre-treatment.
Time frame: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)
The Number of Subjects With Clinically Significant Changes in Urine pH, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel (Unless Patient is Anuric).
pH of the urine will be measured. Clinically significant changes in urine pH were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in urine pH occurred post-treatment compared to pre-treatment.
Time frame: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)
The Number of Subjects With Clinically Significant Changes in Urine Specific Gravity, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel (Unless Patient is Anuric).
Specific gravity of the urine will be evaluated. Clinically significant changes in urine specific gravity were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in urine specific gravity occurred post-treatment compared to pre-treatment.
Time frame: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)
The Number of Subjects With Clinically Significant Changes in Urine Protein Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel (Unless Patient is Anuric).
Protein levels in the urine will be evaluated. Clinically significant changes in urine protein levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in urine protein levels occurred post-treatment compared to pre-treatment.
Time frame: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)
The Number of Subjects With Clinically Significant Changes in Urine Glucose Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel (Unless Patient is Anuric).
Glucose levels in the urine will be evaluated. Clinically significant changes in urine glucose levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in urine glucose levels occurred post-treatment compared to pre-treatment.
Time frame: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)
The Number of Subjects With Clinically Significant Changes in Urine Ketone Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel (Unless Patient is Anuric).
Ketone levels in the urine will be evaluated. Clinically significant changes in urine ketone levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in urine ketone levels occurred post-treatment compared to pre-treatment.
Time frame: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)
The Number of Subjects With Clinically Significant Changes in Urine Bilirubin Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel (Unless Patient is Anuric).
Bilirubin levels in the urine will be evaluated. Clinically significant changes in urine bilirubin levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in urine bilirubin levels occurred post-treatment compared to pre-treatment.
Time frame: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)
The Number of Subjects With Clinically Significant Changes in Urine Blood Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel (Unless Patient is Anuric).
Blood levels in the urine will be evaluated. Clinically significant changes in urine blood levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in urine blood levels occurred post-treatment compared to pre-treatment.
Time frame: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)
The Number of Subjects With Clinically Significant Changes in Urine Nitrite Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel (Unless Patient is Anuric).
Nitrite levels in the urine will be evaluated. Clinically significant changes in urine nitrite levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in urine nitrite levels occurred post-treatment compared to pre-treatment.
Time frame: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)
The Number of Subjects With Clinically Significant Changes in Urine Urobilinogen Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel (Unless Patient is Anuric).
Urobilinogen levels in the urine will be evaluated. Clinically significant changes in urine urobilinogen levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in urine urobilinogen levels occurred post-treatment compared to pre-treatment.
Time frame: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)
The Number of Subjects With Clinically Significant Changes in Urine Leukocyte Esterase Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel (Unless Patient is Anuric).
Leukocyte esterase levels in the urine will be evaluated. Clinically significant changes in urine leukocyte esterase were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in urine leukocyte esterase occurred post-treatment compared to pre-treatment.
Time frame: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)
Hemodialysis Efficiency as Measured by Frequency of Clotting on the Dialysis Filters and Circuit (Pharmacodynamic Outcome).
Assessment of thrombus accumulation in the dialyzer cartridge measured by visual inspection.
Time frame: At each hemodialysis session (pre-dose days: study day -7, -5, -3, and post-dose dose days: study day 1, 3, and 5)
Hemodialysis Efficiency as Measured by Blood Urea Nitrogen (BUN) Levels (Pharmacodynamic Outcome).
Assessment of BUN (mg/dL) before and after hemodialysis as urea reduction ratio (URR), %.
Time frame: 21 days
Hemodialysis Efficiency as Measured by Blood Urea Nitrogen (BUN) Levels (Pharmacodynamic Outcome), KtV.
Assessment of BUN (mg/dL) before and after hemodialysis as KtV (mL/min).
Time frame: 21 days
Hemodialysis Efficiency as Measured by Blood Potassium Levels (Pharmacodynamic Outcome).
Assessment of plasma potassium (mEq/L) before and after hemodialysis. The reduction of plasma potassium (before hemodialysis minus after hemodialysis) is reported in mEq/L).
Time frame: 21 days
Hemodialysis Efficiency as Measured by Length of the Hemodialysis Session (Pharmacodynamic Outcome).
The length of each hemodialysis session will be recorded.
Time frame: 21 days
The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) (Pharmacodynamic Outcome).
Activated partial thromboplastin time (aPTT) will be measured as a pharmacodynamic marker and the change from baseline will be summarized using descriptive statistics. aPTT is a clotting assay that measures how long it takes for blood to clot after clotting is activated by an intrinsic coagulation pathway activator such as kaolin.
Time frame: Study day 1 predose and 0.167, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 96, 120, 168, 216, and 264 hours after dosing
The Maximum Plasma Concentration (Cmax) of Xisomab 3G3 After a Single Injection Will be Measured in Each Patient (Pharmacokinetic Outcome).
Maximum plasma concentration of xisomab 3G3
Time frame: 14 days
The Time to Reach Maximum Plasma Concentrations of Xisomab 3G3 (Tmax) After a Single Injection Will be Measured in Each Patient (Pharmacokinetic Outcome).
The time to reach maximum plasma concentrations of xisomab 3G3 after a single injection.
Time frame: 14 days
The Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Non-zero Concentration (AUC0-t) After a Single Injection of Xisomab 3G3 Will be Calculated for Each Patient (Pharmacokinetic Outcome)
The area under the plasma concentration-time curve from time 0 to the last measurable non-zero concentration.
Time frame: 14 days
The Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) After a Single Injection of Xisomab 3G3 Will be Calculated for Each Patient (Pharmacokinetic Outcome).
The area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) is calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.
Time frame: 14 days
The Percent of AUC0-inf Extrapolated (AUC%Extrap) After a Single Injection of Xisomab 3G3 Will be Calculated for Each Patient (Pharmacokinetic Outcome).
The percent of AUC0-inf extrapolated (AUC%extrap) is calculated by (1-AUC0-t/AUC0-inf)\*100. AUC%extrap represents the fraction of the calculated total area under the curve that was extrapolated after the last measured time point.
Time frame: 14 days
The Apparent First Order Terminal Elimination Rate Constant (Kel) of Xisomab 3G3 After a Single Intravenous Injection Will be Calculated for Each Subject (Pharmacokinetic Outcome).
The apparent first order terminal elimination rate constant will be calculated from a semi-log plot of the plasma concentration versus time curve. The parameter will be calculated by linear least squares regression analysis using the maximum number of points in the terminal log linear phase (e.g., three or more non zero plasma concentrations).
Time frame: 14 days
The Apparent First Order Terminal Elimination Half-life (T1/2) of Xisomab 3G3 After a Single Intravenous Injection Will be Calculated for Each Patient (Pharmacokinetic Outcome).
The apparent first order terminal elimination half-life will be calculated as 0.693/Kel.
Time frame: 14 days
The Apparent Total Plasma Clearance (CL) of Xisomab 3G3 After a Single Intravenous Injection Will be Calculated for Each Patient (Pharmacokinetic Outcome).
The apparent total plasma clearance will be calculated as \[Dose/AUC0-inf\].
Time frame: 14 days
The Total Apparent Volume of Distribution (Vss) of Xisomab 3G3 After a Single Intravenous Injection Will be Calculated for Each Patient (Pharmacokinetic Outcome).
The total apparent volume of distribution (Vss) will be calculated as the mean residence time x clearance.
Time frame: 14 days
| Milestone | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| Started | 8 | 10 | 9 |
| Completed | 8 | 8 | 8 |
| Not completed | 0 | 2 | 1 |
| Withdrew: Physician decision | 0 | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 |
| Milestone | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| Started | 8 | 8 | 8 |
| Completed | 8 | 8 | 8 |
| Not completed | 0 | 0 | 0 |
TEAEs will be determined by physical examination that will include assessment of skin, head, ears, eyes, nose, throat, respiratory system, cardiovascular system, gastrointestinal system, neurological condition, blood and lymphatic systems, and the musculoskeletal system.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Treatment-related Adverse Events (TEAEs) and the Number of TEAEs Will be Summarized Using Frequency Counts (Safety and Tolerability) | 0 | 0 | 0 |
The number of clinically relevant and non-major bleeding events from the vascular access site. Bleeding from the access site was assessed immediately following decannulation. Pressure was placed on the access site for 10 min. After 10 minutes, the access site was checked for bleeding. If still bleeding, pressure was applied for another 5 minutes and checked again. This was repeated until hemostasis was achieved and the time to hemostasis was recorded. A time greater than 10 min was considered a non-major bleeding event.
| events | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| Pre-dose hemodialysis days (days -7, -5, -3) | 0 | 5 | 2 |
| Post-dose hemodialysis days (days 1, 3, 5) | 0 | 5 | 3 |
12-lead electrocardiogram measurement. Abnormal electrocardiogram was determined by the study PI. The result was determined to be treatment-related if the abnormal electrocardiogram occurred post-treatment and not pre-treatment. Data from the specified time points (Study Days 6 and 12) were combined by adding the number of participants on each Study Day that showed an abnormal electrocardiogram compared to pre-treatment (Study Day -8 and Study Day 1, pre-dose).
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Abnormal Electrocardiogram That is Related to Treatment Will be Summarized Using Frequency Counts (Safety and Tolerability). | 0 | 0 | 0 |
Immunogenicity measured by the presence of plasma anti-drug antibodies. Plasma anti-drug antibodies were determined by a validated enzyme-linked immunosorbant assay (ELISA) and the titer of anti-drug antibodies present in patient plasma on Study day 12 was compared to the titer of anti-drug antibodies compared to Study day 1, predose.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects That Develop Treatment-related Immunogenicity Will be Summarized Using Frequency Counts (Safety and Tolerability). | 0 | 0 | 0 |
Body temperature will be measured in degrees Celsius. Clinically significant changes in body temperature were determined by the study PI. The result was determined to be treatment related if the change in body temperature occurred at any time post-treatment and not pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Body Temperature, Frequency, and Relation to Treatment Will be Assessed. | 0 | 0 | 0 |
Respiratory rate will be measured in breaths per minute. Clinically significant changes in respiratory rate were determined by the study PI. The result was determined to be treatment related if the clinically significant changes in respiratory rate occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Respiratory Rate, Frequency, and Relation to Treatment Will be Assessed. | 0 | 0 | 0 |
Systolic and diastolic blood pressure will be measured in mmHg. Clinically significant changes in blood pressure were determined by the study PI. The result was determined to be treatment related if the clinically significant changes in blood pressure occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Blood Pressure (Systolic and Diastolic), Frequency, and Relation to Treatment Will be Assessed. | 0 | 0 | 0 |
Heart rate will be measured in beats per minute. Clinically significant changes in heart rate were determined by the study PI. The result was determined to be treatment related if the clinically significant changes in heart rate occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Heart Rate, Frequency, and Relation to Treatment Will be Assessed. | 0 | 0 | 0 |
Plasma aPTT will be measured in seconds. Clinically significant changes in aPTT were determined by the study PI. The result was determined to be treatment related if the clinically significant changes in aPTT occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Activated Partial Thromboplastin Time (aPTT), Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Coagulation Panel. | 0 | 0 | 0 |
Prothrombin time will be measured in seconds. Clinically significant changes in prothrombin time were determined by the study PI. The result was determined to be treatment related if the clinically significant changes in prothrombin time occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Prothrombin Time, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Coagulation Panel. | 0 | 0 | 0 |
Bilirubin (total and direct) levels in the blood will be measured in mg/dL. Clinically significant changes in bilirubin were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in bilirubin occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Bilirubin (Total and Direct) Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel. | 0 | 0 | 0 |
Alkaline phosphatase levels in the blood will be measured in U/L. Clinically significant changes in alkaline phosphatase were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in alkaline phosphatase occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Alkaline Phosphatase Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel. | 0 | 0 | 0 |
AST levels in the blood will be measured in U/L. Clinically significant changes in aspartate aminotransferase (AST) were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in AST occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Aspartate Aminotransferase (AST) Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel. | 0 | 0 | 0 |
ALT levels in the blood will be measured in U/L. Clinically significant changes in alanine aminotransferase (ALT) were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in ALT occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Alanine Aminotransferase (ALT) Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel. | 0 | 0 | 0 |
LDH levels in the blood will be measured in U/L. Clinically significant changes in lactate dehydrogenase (LDH) were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in LDH occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Lactate Dehydrogenase (LDH) Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel. | 0 | 0 | 0 |
Albumin levels in the blood will be measured in g/dL. Clinically significant changes in albumin were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in albumin occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Albumin Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel. | 0 | 0 | 0 |
Sodium levels will be measured in mEq/L. Clinically significant changes in sodium levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in sodium levels occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Sodium Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel. | 0 | 0 | 0 |
Potassium levels will be measured in mEq/L. Clinically significant changes in potassium levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in potassium levels occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Potassium Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel. | 0 | 0 | 0 |
Chloride levels will be measured in mEq/L. Clinically significant changes in chloride levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in chloride levels occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Chloride Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel. | 0 | 0 | 0 |
Blood glucose levels will be measured in mg/dL. Clinically significant changes in glucose levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in glucose occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Glucose Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel. | 0 | 0 | 0 |
Creatinine levels will be measured in mg/dL. Clinically significant changes in creatinine levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in creatinine levels occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Creatinine Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Serum Chemistry Panel. | 0 | 0 | 0 |
Hemoglobin levels will be measured in g/dL. Clinically significant changes in hemoglobin were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in hemoglobin occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Hemoglobin Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Hematology Panel. | 0 | 0 | 0 |
Hematocrit levels will be measured in %. Clinically significant changes in hematocrit were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in hematocrit occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Hematocrit Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Hematology Panel. | 0 | 0 | 0 |
Total leukocyte counts will be measured in 10˄3/uL. Clinically significant changes in total leukocyte count were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in total leukocyte count occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Total Leukocyte Counts, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Hematology Panel. | 0 | 0 | 0 |
Differential leukocyte counts will be measured in %. Clinically significant changes in differential leukocyte counts were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in differential leukocyte counts occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Differential Leukocyte Counts, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Hematology Panel. | 0 | 0 | 0 |
Red blood cell count will be measured in 10˄6/uL. Clinically significant changes in red blood cell counts were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in red blood cell counts occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Red Blood Cell Count, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Hematology Panel. | 0 | 0 | 0 |
Platelet count will be measured in 10˄3/uL. Clinically significant changes in platelet count were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in platelet count occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Platelet Count, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Hematology Panel. | 0 | 0 | 0 |
pH of the urine will be measured. Clinically significant changes in urine pH were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in urine pH occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Urine pH, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel (Unless Patient is Anuric). | 0 | 0 | 0 |
Specific gravity of the urine will be evaluated. Clinically significant changes in urine specific gravity were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in urine specific gravity occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Urine Specific Gravity, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel (Unless Patient is Anuric). | 0 | 0 | 0 |
Protein levels in the urine will be evaluated. Clinically significant changes in urine protein levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in urine protein levels occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Urine Protein Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel (Unless Patient is Anuric). | 0 | 0 | 0 |
Glucose levels in the urine will be evaluated. Clinically significant changes in urine glucose levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in urine glucose levels occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Urine Glucose Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel (Unless Patient is Anuric). | 0 | 0 | 0 |
Ketone levels in the urine will be evaluated. Clinically significant changes in urine ketone levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in urine ketone levels occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Urine Ketone Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel (Unless Patient is Anuric). | 0 | 0 | 0 |
Bilirubin levels in the urine will be evaluated. Clinically significant changes in urine bilirubin levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in urine bilirubin levels occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Urine Bilirubin Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel (Unless Patient is Anuric). | 0 | 0 | 0 |
Blood levels in the urine will be evaluated. Clinically significant changes in urine blood levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in urine blood levels occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Urine Blood Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel (Unless Patient is Anuric). | 0 | 0 | 0 |
Nitrite levels in the urine will be evaluated. Clinically significant changes in urine nitrite levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in urine nitrite levels occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Urine Nitrite Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel (Unless Patient is Anuric). | 0 | 0 | 0 |
Urobilinogen levels in the urine will be evaluated. Clinically significant changes in urine urobilinogen levels were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in urine urobilinogen levels occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Urine Urobilinogen Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel (Unless Patient is Anuric). | 0 | 0 | 0 |
Leukocyte esterase levels in the urine will be evaluated. Clinically significant changes in urine leukocyte esterase were determined by the study PI. The result was determined to be treatment-related if the clinically significant changes in urine leukocyte esterase occurred post-treatment compared to pre-treatment.
| Participants | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| The Number of Subjects With Clinically Significant Changes in Urine Leukocyte Esterase Levels, Frequency, and Relation to Treatment Will be Assessed as Part of a Standard Urinalysis Panel (Unless Patient is Anuric). | 0 | 0 | 0 |
Assessment of thrombus accumulation in the dialyzer cartridge measured by visual inspection.
| Complete occlusions of filter | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| Pre-dose hemodialysis (days -7, -5, -3) | 2 | 4 | 1 |
| Post-dose hemodialysis (days 1, 3, 5) | 0 | 0 | 0 |
Assessment of BUN (mg/dL) before and after hemodialysis as urea reduction ratio (URR), %.
| URR (%) | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| Pre-dose Day -7 | 66.53 ± 4.734 | 70.59 ± 7.361 | 69.61 ± 6.452 |
| Pre-dose Day -5 | 64.98 ± 4.927 | 70.36 ± 5.759 | 70.37 ± 6.015 |
| Pre-dose Day -3 | 66.67 ± 6.624 | 67.04 ± 10.576 | 68.73 ± 6.378 |
| Post-dose Day 1 | 67.82 ± 6.201 | 69.37 ± 10.440 | 71.36 ± 6.098 |
| Post-dose Day 3 | 67.47 ± 5.496 | 72.14 ± 5.613 | 70.33 ± 6.877 |
| Post-dose Day 5 | 69.63 ± 5.972 | 71.42 ± 6.944 | 71.86 ± 5.864 |
| Post-dose Day 12 | 65.66 ± 8.039 | 72.34 ± 6.749 | 70.98 ± 6.315 |
Assessment of BUN (mg/dL) before and after hemodialysis as KtV (mL/min).
| mL/min | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| Pre-dose Day -7 | 1.312 ± 0.1537 | 1.449 ± 0.3051 | 1.413 ± 0.2359 |
| Pre-dose Day -5 | 1.250 ± 0.1615 | 1.402 ± 0.2467 | 1.432 ± 0.2253 |
| Pre-dose Day -3 | 1.330 ± 0.2078 | 1.337 ± 0.3887 | 1.347 ± 0.2239 |
| Post-dose Day 1 | 1.386 ± 0.2311 | 1.438 ± 0.4005 | 1.492 ± 0.2424 |
| Post-dose Day 3 | 1.399 ± 0.1894 | 1.509 ± 0.2505 | 1.431 ± 0.2482 |
| Post-dose Day 5 | 1.393 ± 0.1841 | 1.494 ± 0.3209 | 1.451 ± 0.2383 |
| Post-dose Day 12 | 1.253 ± 0.2267 | 1.527 ± 0.3107 | 1.478 ± 0.2480 |
Assessment of plasma potassium (mEq/L) before and after hemodialysis. The reduction of plasma potassium (before hemodialysis minus after hemodialysis) is reported in mEq/L).
| mEq/mL | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| Pre-dose Day -7 | 1.68 ± 0.648 | 1.60 ± 0.595 | 1.69 ± 0.722 |
| Pre-dose Day -5 | 1.57 ± 0.769 | 1.44 ± 0.802 | 1.71 ± 0.770 |
| Pre-dose Day -3 | 1.44 ± 0.668 | 1.41 ± 0.308 | 1.63 ± 0.590 |
| Post-dose Day 1 | 2.11 ± 0.405 | 1.66 ± 0.862 | 2.05 ± 1.207 |
| Post-dose Day 3 | 2.11 ± 0.603 | 1.81 ± 0.521 | 1.58 ± 0.861 |
| Post-dose Day 5 | 2.00 ± 0.504 | 1.70 ± 0.751 | 1.99 ± 0.734 |
| Post-dose Day 12 | 1.24 ± 0.566 | 1.45 ± 0.389 | 1.39 ± 0.813 |
The length of each hemodialysis session will be recorded.
| minutes | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| Pre-dose Day -7 | 235 ± 8.44 | 237 ± 4.84 | 240 ± 0.00 |
| Pre-dose Day -5 | 240 ± 7.75 | 234 ± 8.89 | 240 ± 0.00 |
| Pre-dose Day -3 | 242 ± 4.60 | 239 ± 3.54 | 240 ± 0.00 |
| Post-dose Day 1 | 233 ± 15.9 | 232 ± 15.6 | 240 ± 0.00 |
| Post-dose Day 3 | 240 ± 0.00 | 235 ± 12.6 | 240 ± 0.00 |
| Post-dose Day 5 | 240 ± 0.00 | 239 ± 1.77 | 240 ± 0.00 |
| Post-dose Day 12 | 232 ± 14.1 | 239 ± 3.18 | 240 ± 0.00 |
Activated partial thromboplastin time (aPTT) will be measured as a pharmacodynamic marker and the change from baseline will be summarized using descriptive statistics. aPTT is a clotting assay that measures how long it takes for blood to clot after clotting is activated by an intrinsic coagulation pathway activator such as kaolin.
| seconds | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| 0h | 39.1 ± 7.90 | 42.2 ± 4.84 | 39.1 ± 4.29 |
| 0.167h | 82.2 ± 19.7 | 92.3 ± 11.8 | 42.5 ± 9.00 |
| 0.5h | 80.6 ± 18.8 | 91.9 ± 12.8 | 38.2 ± 5.16 |
| 1h | 77.9 ± 22.3 | 91.4 ± 12.5 | 38.2 ± 6.08 |
| 2h | 83.5 ± 23.3 | 89.9 ± 11.4 | 38.5 ± 5.87 |
| 3h | 90.9 ± 21.5 | 93.7 ± 4.5 | 39.3 ± 6.54 |
| 4h | 88.9 ± 21.5 | 96.0 ± 11.7 | 41.5 ± 9.15 |
| 6h | 87.6 ± 19.9 | 92.5 ± 10.1 | 39.4 ± 6.97 |
| 8h | 75.8 ± 19.490 | 83.9 ± 5.2 | 38.1 ± 4.40 |
| 12h | 72.2 ± 17.7 | 86.1 ± 8.2 | 41.4 ± 15.7 |
| 16h | 68.0 ± 17.9 | 84.1 ± 9.10 | 40.7 ± 5.76 |
| 24h | 69.8 ± 21.7 | 89.6 ± 10.1 | 36.9 ± 5.56 |
| 48h | 60.9 ± 20.9 | 85.3 ± 7.30 | 37.0 ± 5.01 |
| 96h | 54.3 ± 10.8 | 83.5 ± 27.2 | 40.1 ± 8.25 |
| 120h | 55.4 ± 16.3 | 66.3 ± 16.9 | 46.1 ± 9.03 |
| 168h | 41.0 ± 5.4 | 59.4 ± 23.3 | 39.8 ± 9.03 |
| 216h | 41.8 ± 5.5 | 52.6 ± 17.2 | 39.0 ± 8.19 |
| 264h | 44.2 ± 8.019 | 46.6 ± 9.94 | 39.6 ± 5.87 |
Maximum plasma concentration of xisomab 3G3
| ng/mL | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 |
|---|---|---|
| The Maximum Plasma Concentration (Cmax) of Xisomab 3G3 After a Single Injection Will be Measured in Each Patient (Pharmacokinetic Outcome). | 1918 ± 120.6 | 7557 ± 33.5 |
The time to reach maximum plasma concentrations of xisomab 3G3 after a single injection.
| hours | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 |
|---|---|---|
| The Time to Reach Maximum Plasma Concentrations of Xisomab 3G3 (Tmax) After a Single Injection Will be Measured in Each Patient (Pharmacokinetic Outcome). | 0.167 (0.167 to 3.00) | 0.750 (0.167 to 2.00) |
The area under the plasma concentration-time curve from time 0 to the last measurable non-zero concentration.
| ng*hr/mL | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 |
|---|---|---|
| The Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Non-zero Concentration (AUC0-t) After a Single Injection of Xisomab 3G3 Will be Calculated for Each Patient (Pharmacokinetic Outcome) | 22330 ± 214.7 | 256300 ± 46.9 |
The area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) is calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant.
| ng*hr/mL | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 |
|---|---|---|
| The Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) After a Single Injection of Xisomab 3G3 Will be Calculated for Each Patient (Pharmacokinetic Outcome). | 39010 ± 101.5 | 273200 ± 54.6 |
The percent of AUC0-inf extrapolated (AUC%extrap) is calculated by (1-AUC0-t/AUC0-inf)\*100. AUC%extrap represents the fraction of the calculated total area under the curve that was extrapolated after the last measured time point.
| percent of AUC that was extrapolated | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 |
|---|---|---|
| The Percent of AUC0-inf Extrapolated (AUC%Extrap) After a Single Injection of Xisomab 3G3 Will be Calculated for Each Patient (Pharmacokinetic Outcome). | 13.55 ± 11.619 | 5.846 ± 8.0195 |
The apparent first order terminal elimination rate constant will be calculated from a semi-log plot of the plasma concentration versus time curve. The parameter will be calculated by linear least squares regression analysis using the maximum number of points in the terminal log linear phase (e.g., three or more non zero plasma concentrations).
| 1/hr | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 |
|---|---|---|
| The Apparent First Order Terminal Elimination Rate Constant (Kel) of Xisomab 3G3 After a Single Intravenous Injection Will be Calculated for Each Subject (Pharmacokinetic Outcome). | 0.08800 ± 0.073260 | 0.03027 ± 0.010510 |
The apparent first order terminal elimination half-life will be calculated as 0.693/Kel.
| hours | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 |
|---|---|---|
| The Apparent First Order Terminal Elimination Half-life (T1/2) of Xisomab 3G3 After a Single Intravenous Injection Will be Calculated for Each Patient (Pharmacokinetic Outcome). | 11.125 ± 5.3961 | 27.082 ± 15.1722 |
The apparent total plasma clearance will be calculated as \[Dose/AUC0-inf\].
| mL/hr | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 |
|---|---|---|
| The Apparent Total Plasma Clearance (CL) of Xisomab 3G3 After a Single Intravenous Injection Will be Calculated for Each Patient (Pharmacokinetic Outcome). | 773.6 ± 612.47 | 155.0 ± 42.374 |
The total apparent volume of distribution (Vss) will be calculated as the mean residence time x clearance.
| mL | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 |
|---|---|---|
| The Total Apparent Volume of Distribution (Vss) of Xisomab 3G3 After a Single Intravenous Injection Will be Calculated for Each Patient (Pharmacokinetic Outcome). | 9945 ± 5014.8 | 5498 ± 793.78 |
Collected over Adverse event data was collected from study check in (Day -8) through the final follow up (Day 12) for a total of 21 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AB023 (Xisomab 3G3)- Dose 1 | 0/8 (0%) | 0/8 (0%) | 2/8 (25%) |
| AB023 (Xisomab 3G3)- Dose 2 | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Placebo | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) |
| Event | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo |
|---|---|---|---|
| Viral gastroenteritisInfections and infestations | 2/8 | 0/8 | 1/8 |
| Age, Continuous(years) | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo | Total |
|---|---|---|---|---|
| Mean | 55.8 ± 7.59 | 53.1 ± 5.30 | 52.6 ± 9.21 | 53.8 ± 7.34 |
| Sex: Female, Male(Participants) | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo | Total |
|---|---|---|---|---|
| Female | 1 | 3 | 1 | 5 |
| Male | 7 | 5 | 7 | 19 |
| Ethnicity (NIH/OMB)(Participants) | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 2 | 2 |
| Not Hispanic or Latino | 8 | 8 | 6 | 22 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 8 | 7 | 6 | 21 |
| White | 0 | 1 | 2 | 3 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | AB023 (Xisomab 3G3)- Dose 1 | AB023 (Xisomab 3G3)- Dose 2 | Placebo | Total |
|---|---|---|---|---|
| United States | 8 | 8 | 8 | 8 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All subject-level clinical, laboratory, samples and imaging data as well as protocols, informed consent forms to participate in the trial, data dictionary, and code book will be preserved for data sharing. Shared data will be deidentifed and all raw data generated in connection with this study will be retained by the Investigator's institution. All data will be shared with controlled access. Prior to granting access outside of the Sponsor's archive, data will be deidentified by removing all 18 direct identifiers according to HIPAA Privacy Rule's Safe Harbor.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data underlying the reported results will be made available 3 months after publication in a peer-reviewed journal for a period of 5 years.
Access criteria: Potential parties from other organizations can learn about study data and identify whether it could be suitable for their research purposes though summary information (ClinicalTrials.gov, Pubmed) that will be readily available on our website. Requests for data can be made directly to Aronora, Inc.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: AB023
Aronora, Inc.