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Trial Outcomes & Findings for Safety and Efficacy Study of AB023 (Xisomab 3G3) in End Stage Renal Disease Patients on Chronic Hemodialysis (NCT NCT03612856)

NCT ID: NCT03612856

Last Updated: 2024-03-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

21 days

Results posted on

2024-03-07

Participant Flow

A total of 37 participants were screened for the study, of which 10 did not meet eligibility criteria. The remaining 27 participants were enrolled. 3 participants terminated the study prior to randomization either by withdrawing consent or at the PI's discretion. The remaining 24 participants were randomized into the study and dosed.

Participant milestones

Participant milestones
Measure
AB023 (Xisomab 3G3)- Dose 1
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of placebo.
Pre-dose Period
STARTED
8
10
9
Pre-dose Period
COMPLETED
8
8
8
Pre-dose Period
NOT COMPLETED
0
2
1
Post-dose Period
STARTED
8
8
8
Post-dose Period
COMPLETED
8
8
8
Post-dose Period
NOT COMPLETED
0
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
AB023 (Xisomab 3G3)- Dose 1
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of placebo.
Pre-dose Period
Physician Decision
0
1
1
Pre-dose Period
Withdrawal by Subject
0
1
0

Baseline Characteristics

Safety and Efficacy Study of AB023 (Xisomab 3G3) in End Stage Renal Disease Patients on Chronic Hemodialysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of placebo.
Total
n=24 Participants
Total of all reporting groups
Age, Continuous
55.8 years
STANDARD_DEVIATION 7.59 • n=99 Participants
53.1 years
STANDARD_DEVIATION 5.30 • n=107 Participants
52.6 years
STANDARD_DEVIATION 9.21 • n=206 Participants
53.8 years
STANDARD_DEVIATION 7.34 • n=7 Participants
Sex: Female, Male
Female
1 Participants
n=99 Participants
3 Participants
n=107 Participants
1 Participants
n=206 Participants
5 Participants
n=7 Participants
Sex: Female, Male
Male
7 Participants
n=99 Participants
5 Participants
n=107 Participants
7 Participants
n=206 Participants
19 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
0 Participants
n=107 Participants
2 Participants
n=206 Participants
2 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
8 Participants
n=99 Participants
8 Participants
n=107 Participants
6 Participants
n=206 Participants
22 Participants
n=7 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
Black or African American
8 Participants
n=99 Participants
7 Participants
n=107 Participants
6 Participants
n=206 Participants
21 Participants
n=7 Participants
Race (NIH/OMB)
White
0 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
3 Participants
n=7 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
Region of Enrollment
United States
8 participants
n=99 Participants
8 participants
n=107 Participants
8 participants
n=206 Participants
8 participants
n=7 Participants

PRIMARY outcome

Timeframe: 21 days

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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: 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)
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study Days -7, -5, -3 (pre-dose) 1, 3, and 5 (post-dose)

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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of placebo.
Incidence of Bleeding at the HD Vascular Access Site (Safety and Tolerability)
Pre-dose hemodialysis days (days -7, -5, -3)
0 events
5 events
2 events
Incidence of Bleeding at the HD Vascular Access Site (Safety and Tolerability)
Post-dose hemodialysis days (days 1, 3, 5)
0 events
5 events
3 events

PRIMARY outcome

Timeframe: Study Days -8 and 1, pre-dose (pre-treatment) and Study Days 6 and 12 (post-treatment)

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).

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of placebo.
The Number of Subjects With Abnormal Electrocardiogram That is Related to Treatment Will be Summarized Using Frequency Counts (Safety and Tolerability).
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study day 1 (predose) and Study Day 12

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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of placebo.
The Number of Subjects That Develop Treatment-related Immunogenicity Will be Summarized Using Frequency Counts (Safety and Tolerability).
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of placebo.
The Number of Subjects With Clinically Significant Changes in Body Temperature, Frequency, and Relation to Treatment Will be Assessed.
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of placebo.
The Number of Subjects With Clinically Significant Changes in Respiratory Rate, Frequency, and Relation to Treatment Will be Assessed.
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of placebo.
The Number of Subjects With Clinically Significant Changes in Blood Pressure (Systolic and Diastolic), Frequency, and Relation to Treatment Will be Assessed.
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of placebo.
The Number of Subjects With Clinically Significant Changes in Heart Rate, Frequency, and Relation to Treatment Will be Assessed.
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study days -7, -5, -3, and 1 (pre-treatment) and study days 1 (3h post-dose), 3, 5, 6, and 12 (post-treatment).

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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of 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 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study days -7, -5, -3, and 1 (pre-treatment) and study days 1 (3h post-dose), 3, 5, 6, and 12 (post-treatment).

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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of 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 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of 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 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of 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 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of 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 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of 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 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of 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 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of 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 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of 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 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of 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 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of 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 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of 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 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of 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 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of 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 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of 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 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of 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 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of 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 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of 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 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of 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 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

Population: Only one subject in the study was able to produce urine. The rest were 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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=1 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of 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 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

Population: Only one subject in the study was able to produce urine. The rest were 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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=1 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of 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 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

Population: Only one subject in the study was able to produce urine. The rest were 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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=1 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of 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 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

Population: Only one subject in the study was able to produce urine. The rest were 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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=1 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of 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 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

Population: Only one subject in the study was able to produce urine. The rest were 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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=1 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of 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 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

Population: Only one subject in the study was able to produce urine. The rest were 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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=1 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of 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 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

Population: Only one subject in the study was able to produce urine. The rest were 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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=1 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of 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 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

Population: Only one subject in the study was able to produce urine. The rest were 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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=1 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of 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 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

Population: Only one subject in the study was able to produce urine. The rest were 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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=1 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of 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 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Study day 1 (pre-treatment), and study days 6 and 12 (post-treatment)

Population: Only one subject in the study was able to produce urine. The rest were 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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=1 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of 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 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: At each hemodialysis session (pre-dose days: study day -7, -5, -3, and post-dose dose days: study day 1, 3, and 5)

Assessment of thrombus accumulation in the dialyzer cartridge measured by visual inspection.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of placebo.
Hemodialysis Efficiency as Measured by Frequency of Clotting on the Dialysis Filters and Circuit (Pharmacodynamic Outcome).
Pre-dose hemodialysis (days -7, -5, -3)
2 Complete occlusions of filter
4 Complete occlusions of filter
1 Complete occlusions of filter
Hemodialysis Efficiency as Measured by Frequency of Clotting on the Dialysis Filters and Circuit (Pharmacodynamic Outcome).
Post-dose hemodialysis (days 1, 3, 5)
0 Complete occlusions of filter
0 Complete occlusions of filter
0 Complete occlusions of filter

SECONDARY outcome

Timeframe: 21 days

Population: In a few instances, the pre- and post-dialysis values appeared to be switched and were excluded from the summary statistics or a value was missing or not reportable.

Assessment of BUN (mg/dL) before and after hemodialysis as urea reduction ratio (URR), %.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of placebo.
Hemodialysis Efficiency as Measured by Blood Urea Nitrogen (BUN) Levels (Pharmacodynamic Outcome).
Pre-dose Day -7
66.53 URR (%)
Standard Deviation 4.734
70.59 URR (%)
Standard Deviation 7.361
69.61 URR (%)
Standard Deviation 6.452
Hemodialysis Efficiency as Measured by Blood Urea Nitrogen (BUN) Levels (Pharmacodynamic Outcome).
Pre-dose Day -5
64.98 URR (%)
Standard Deviation 4.927
70.36 URR (%)
Standard Deviation 5.759
70.37 URR (%)
Standard Deviation 6.015
Hemodialysis Efficiency as Measured by Blood Urea Nitrogen (BUN) Levels (Pharmacodynamic Outcome).
Pre-dose Day -3
66.67 URR (%)
Standard Deviation 6.624
67.04 URR (%)
Standard Deviation 10.576
68.73 URR (%)
Standard Deviation 6.378
Hemodialysis Efficiency as Measured by Blood Urea Nitrogen (BUN) Levels (Pharmacodynamic Outcome).
Post-dose Day 1
67.82 URR (%)
Standard Deviation 6.201
69.37 URR (%)
Standard Deviation 10.440
71.36 URR (%)
Standard Deviation 6.098
Hemodialysis Efficiency as Measured by Blood Urea Nitrogen (BUN) Levels (Pharmacodynamic Outcome).
Post-dose Day 3
67.47 URR (%)
Standard Deviation 5.496
72.14 URR (%)
Standard Deviation 5.613
70.33 URR (%)
Standard Deviation 6.877
Hemodialysis Efficiency as Measured by Blood Urea Nitrogen (BUN) Levels (Pharmacodynamic Outcome).
Post-dose Day 5
69.63 URR (%)
Standard Deviation 5.972
71.42 URR (%)
Standard Deviation 6.944
71.86 URR (%)
Standard Deviation 5.864
Hemodialysis Efficiency as Measured by Blood Urea Nitrogen (BUN) Levels (Pharmacodynamic Outcome).
Post-dose Day 12
65.66 URR (%)
Standard Deviation 8.039
72.34 URR (%)
Standard Deviation 6.749
70.98 URR (%)
Standard Deviation 6.315

SECONDARY outcome

Timeframe: 21 days

Population: In a few instances, the pre- and post-dialysis values appeared to be switched and were excluded from the summary statistics or a value was missing or not reportable.

Assessment of BUN (mg/dL) before and after hemodialysis as KtV (mL/min).

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of placebo.
Hemodialysis Efficiency as Measured by Blood Urea Nitrogen (BUN) Levels (Pharmacodynamic Outcome), KtV.
Pre-dose Day -7
1.312 mL/min
Standard Deviation 0.1537
1.449 mL/min
Standard Deviation 0.3051
1.413 mL/min
Standard Deviation 0.2359
Hemodialysis Efficiency as Measured by Blood Urea Nitrogen (BUN) Levels (Pharmacodynamic Outcome), KtV.
Pre-dose Day -5
1.250 mL/min
Standard Deviation 0.1615
1.402 mL/min
Standard Deviation 0.2467
1.432 mL/min
Standard Deviation 0.2253
Hemodialysis Efficiency as Measured by Blood Urea Nitrogen (BUN) Levels (Pharmacodynamic Outcome), KtV.
Pre-dose Day -3
1.330 mL/min
Standard Deviation 0.2078
1.337 mL/min
Standard Deviation 0.3887
1.347 mL/min
Standard Deviation 0.2239
Hemodialysis Efficiency as Measured by Blood Urea Nitrogen (BUN) Levels (Pharmacodynamic Outcome), KtV.
Post-dose Day 1
1.386 mL/min
Standard Deviation 0.2311
1.438 mL/min
Standard Deviation 0.4005
1.492 mL/min
Standard Deviation 0.2424
Hemodialysis Efficiency as Measured by Blood Urea Nitrogen (BUN) Levels (Pharmacodynamic Outcome), KtV.
Post-dose Day 3
1.399 mL/min
Standard Deviation 0.1894
1.509 mL/min
Standard Deviation 0.2505
1.431 mL/min
Standard Deviation 0.2482
Hemodialysis Efficiency as Measured by Blood Urea Nitrogen (BUN) Levels (Pharmacodynamic Outcome), KtV.
Post-dose Day 5
1.393 mL/min
Standard Deviation 0.1841
1.494 mL/min
Standard Deviation 0.3209
1.451 mL/min
Standard Deviation 0.2383
Hemodialysis Efficiency as Measured by Blood Urea Nitrogen (BUN) Levels (Pharmacodynamic Outcome), KtV.
Post-dose Day 12
1.253 mL/min
Standard Deviation 0.2267
1.527 mL/min
Standard Deviation 0.3107
1.478 mL/min
Standard Deviation 0.2480

SECONDARY outcome

Timeframe: 21 days

Population: In a few instances, the pre- and post-dialysis values appeared to be switched and were excluded from the summary statistics or a value was missing or not reportable.

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).

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of placebo.
Hemodialysis Efficiency as Measured by Blood Potassium Levels (Pharmacodynamic Outcome).
Pre-dose Day -7
1.68 mEq/mL
Standard Deviation 0.648
1.60 mEq/mL
Standard Deviation 0.595
1.69 mEq/mL
Standard Deviation 0.722
Hemodialysis Efficiency as Measured by Blood Potassium Levels (Pharmacodynamic Outcome).
Pre-dose Day -5
1.57 mEq/mL
Standard Deviation 0.769
1.44 mEq/mL
Standard Deviation 0.802
1.71 mEq/mL
Standard Deviation 0.770
Hemodialysis Efficiency as Measured by Blood Potassium Levels (Pharmacodynamic Outcome).
Pre-dose Day -3
1.44 mEq/mL
Standard Deviation 0.668
1.41 mEq/mL
Standard Deviation 0.308
1.63 mEq/mL
Standard Deviation 0.590
Hemodialysis Efficiency as Measured by Blood Potassium Levels (Pharmacodynamic Outcome).
Post-dose Day 1
2.11 mEq/mL
Standard Deviation 0.405
1.66 mEq/mL
Standard Deviation 0.862
2.05 mEq/mL
Standard Deviation 1.207
Hemodialysis Efficiency as Measured by Blood Potassium Levels (Pharmacodynamic Outcome).
Post-dose Day 3
2.11 mEq/mL
Standard Deviation 0.603
1.81 mEq/mL
Standard Deviation 0.521
1.58 mEq/mL
Standard Deviation 0.861
Hemodialysis Efficiency as Measured by Blood Potassium Levels (Pharmacodynamic Outcome).
Post-dose Day 5
2.00 mEq/mL
Standard Deviation 0.504
1.70 mEq/mL
Standard Deviation 0.751
1.99 mEq/mL
Standard Deviation 0.734
Hemodialysis Efficiency as Measured by Blood Potassium Levels (Pharmacodynamic Outcome).
Post-dose Day 12
1.24 mEq/mL
Standard Deviation 0.566
1.45 mEq/mL
Standard Deviation 0.389
1.39 mEq/mL
Standard Deviation 0.813

SECONDARY outcome

Timeframe: 21 days

The length of each hemodialysis session will be recorded.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of placebo.
Hemodialysis Efficiency as Measured by Length of the Hemodialysis Session (Pharmacodynamic Outcome).
Post-dose Day 3
240 minutes
Standard Deviation 0.00
235 minutes
Standard Deviation 12.6
240 minutes
Standard Deviation 0.00
Hemodialysis Efficiency as Measured by Length of the Hemodialysis Session (Pharmacodynamic Outcome).
Pre-dose Day -5
240 minutes
Standard Deviation 7.75
234 minutes
Standard Deviation 8.89
240 minutes
Standard Deviation 0.00
Hemodialysis Efficiency as Measured by Length of the Hemodialysis Session (Pharmacodynamic Outcome).
Pre-dose Day -3
242 minutes
Standard Deviation 4.60
239 minutes
Standard Deviation 3.54
240 minutes
Standard Deviation 0.00
Hemodialysis Efficiency as Measured by Length of the Hemodialysis Session (Pharmacodynamic Outcome).
Post-dose Day 1
233 minutes
Standard Deviation 15.9
232 minutes
Standard Deviation 15.6
240 minutes
Standard Deviation 0.00
Hemodialysis Efficiency as Measured by Length of the Hemodialysis Session (Pharmacodynamic Outcome).
Post-dose Day 5
240 minutes
Standard Deviation 0.00
239 minutes
Standard Deviation 1.77
240 minutes
Standard Deviation 0.00
Hemodialysis Efficiency as Measured by Length of the Hemodialysis Session (Pharmacodynamic Outcome).
Post-dose Day 12
232 minutes
Standard Deviation 14.1
239 minutes
Standard Deviation 3.18
240 minutes
Standard Deviation 0.00
Hemodialysis Efficiency as Measured by Length of the Hemodialysis Session (Pharmacodynamic Outcome).
Pre-dose Day -7
235 minutes
Standard Deviation 8.44
237 minutes
Standard Deviation 4.84
240 minutes
Standard Deviation 0.00

SECONDARY outcome

Timeframe: 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

Population: In one instance, the aPTT value was missing or not reportable.

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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 Participants
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of placebo.
The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) (Pharmacodynamic Outcome).
8h
75.8 seconds
Standard Deviation 19.490
83.9 seconds
Standard Deviation 5.2
38.1 seconds
Standard Deviation 4.40
The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) (Pharmacodynamic Outcome).
12h
72.2 seconds
Standard Deviation 17.7
86.1 seconds
Standard Deviation 8.2
41.4 seconds
Standard Deviation 15.7
The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) (Pharmacodynamic Outcome).
16h
68.0 seconds
Standard Deviation 17.9
84.1 seconds
Standard Deviation 9.10
40.7 seconds
Standard Deviation 5.76
The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) (Pharmacodynamic Outcome).
24h
69.8 seconds
Standard Deviation 21.7
89.6 seconds
Standard Deviation 10.1
36.9 seconds
Standard Deviation 5.56
The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) (Pharmacodynamic Outcome).
48h
60.9 seconds
Standard Deviation 20.9
85.3 seconds
Standard Deviation 7.30
37.0 seconds
Standard Deviation 5.01
The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) (Pharmacodynamic Outcome).
6h
87.6 seconds
Standard Deviation 19.9
92.5 seconds
Standard Deviation 10.1
39.4 seconds
Standard Deviation 6.97
The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) (Pharmacodynamic Outcome).
0h
39.1 seconds
Standard Deviation 7.90
42.2 seconds
Standard Deviation 4.84
39.1 seconds
Standard Deviation 4.29
The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) (Pharmacodynamic Outcome).
0.167h
82.2 seconds
Standard Deviation 19.7
92.3 seconds
Standard Deviation 11.8
42.5 seconds
Standard Deviation 9.00
The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) (Pharmacodynamic Outcome).
0.5h
80.6 seconds
Standard Deviation 18.8
91.9 seconds
Standard Deviation 12.8
38.2 seconds
Standard Deviation 5.16
The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) (Pharmacodynamic Outcome).
1h
77.9 seconds
Standard Deviation 22.3
91.4 seconds
Standard Deviation 12.5
38.2 seconds
Standard Deviation 6.08
The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) (Pharmacodynamic Outcome).
2h
83.5 seconds
Standard Deviation 23.3
89.9 seconds
Standard Deviation 11.4
38.5 seconds
Standard Deviation 5.87
The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) (Pharmacodynamic Outcome).
3h
90.9 seconds
Standard Deviation 21.5
93.7 seconds
Standard Deviation 4.5
39.3 seconds
Standard Deviation 6.54
The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) (Pharmacodynamic Outcome).
4h
88.9 seconds
Standard Deviation 21.5
96.0 seconds
Standard Deviation 11.7
41.5 seconds
Standard Deviation 9.15
The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) (Pharmacodynamic Outcome).
96h
54.3 seconds
Standard Deviation 10.8
83.5 seconds
Standard Deviation 27.2
40.1 seconds
Standard Deviation 8.25
The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) (Pharmacodynamic Outcome).
120h
55.4 seconds
Standard Deviation 16.3
66.3 seconds
Standard Deviation 16.9
46.1 seconds
Standard Deviation 9.03
The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) (Pharmacodynamic Outcome).
168h
41.0 seconds
Standard Deviation 5.4
59.4 seconds
Standard Deviation 23.3
39.8 seconds
Standard Deviation 9.03
The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) (Pharmacodynamic Outcome).
216h
41.8 seconds
Standard Deviation 5.5
52.6 seconds
Standard Deviation 17.2
39.0 seconds
Standard Deviation 8.19
The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) (Pharmacodynamic Outcome).
264h
44.2 seconds
Standard Deviation 8.019
46.6 seconds
Standard Deviation 9.94
39.6 seconds
Standard Deviation 5.87

SECONDARY outcome

Timeframe: 14 days

Population: One subject (0.25 mg/kg xisomab 3G3) was excluded from the summary statistics since the 0.17 hr Xisomab 3G3 concentration was suspected to be an outlier.

Maximum plasma concentration of xisomab 3G3

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=7 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of placebo.
The Maximum Plasma Concentration (Cmax) of Xisomab 3G3 After a Single Injection Will be Measured in Each Patient (Pharmacokinetic Outcome).
1918 ng/mL
Geometric Coefficient of Variation 120.6
7557 ng/mL
Geometric Coefficient of Variation 33.5
—

SECONDARY outcome

Timeframe: 14 days

Population: One subject (0.25 mg/kg xisomab 3G3) was excluded from the summary statistics since the 0.17 hr Xisomab 3G3 concentration was suspected to be an outlier.

The time to reach maximum plasma concentrations of xisomab 3G3 after a single injection.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=7 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of placebo.
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 hours
Interval 0.167 to 3.0
0.750 hours
Interval 0.167 to 2.0
—

SECONDARY outcome

Timeframe: 14 days

Population: One subject (0.25 mg/kg xisomab 3G3) was excluded from the summary statistics since the 0.17 hr Xisomab 3G3 concentration was suspected to be an outlier.

The area under the plasma concentration-time curve from time 0 to the last measurable non-zero concentration.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=7 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=7 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of placebo.
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 ng*hr/mL
Geometric Coefficient of Variation 214.7
256300 ng*hr/mL
Geometric Coefficient of Variation 46.9
—

SECONDARY outcome

Timeframe: 14 days

Population: One subject (0.25 mg/kg xisomab 3G3) was excluded from the summary statistics since the 0.17 hr Xisomab 3G3 concentration was suspected to be an outlier. One subject (0.25 mg/kg xisomab 3G3) had an AUC%extrap that was very high (63%) and therefore was excluded.

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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=6 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of placebo.
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 ng*hr/mL
Geometric Coefficient of Variation 101.5
273200 ng*hr/mL
Geometric Coefficient of Variation 54.6
—

SECONDARY outcome

Timeframe: 14 days

Population: One subject (0.25 mg/kg xisomab 3G3) was excluded from the summary statistics since the 0.17 hr Xisomab 3G3 concentration was suspected to be an outlier. One subject (0.25 mg/kg xisomab 3G3) had an AUC%extrap that was very high (63%) and therefore was excluded.

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.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=6 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of placebo.
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 percent of AUC that was extrapolated
Standard Deviation 11.619
5.846 percent of AUC that was extrapolated
Standard Deviation 8.0195
—

SECONDARY outcome

Timeframe: 14 days

Population: One subject (0.25 mg/kg xisomab 3G3) was excluded from the summary statistics since the 0.17 hr Xisomab 3G3 concentration was suspected to be an outlier. One subject (0.25 mg/kg xisomab 3G3) had an AUC%extrap that was very high (63%) and therefore was excluded.

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).

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=6 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of placebo.
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 1/hr
Standard Deviation 0.073260
0.03027 1/hr
Standard Deviation 0.010510
—

SECONDARY outcome

Timeframe: 14 days

Population: One subject (0.25 mg/kg xisomab 3G3) was excluded from the summary statistics since the 0.17 hr Xisomab 3G3 concentration was suspected to be an outlier. One subject (0.25 mg/kg xisomab 3G3) had an AUC%extrap that was very high (63%) and therefore was excluded.

The apparent first order terminal elimination half-life will be calculated as 0.693/Kel.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=6 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of placebo.
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 hours
Standard Deviation 5.3961
27.082 hours
Standard Deviation 15.1722
—

SECONDARY outcome

Timeframe: 14 days

Population: One subject (0.25 mg/kg xisomab 3G3) was excluded from the summary statistics since the 0.17 hr Xisomab 3G3 concentration was suspected to be an outlier. One subject (0.25 mg/kg xisomab 3G3) had an AUC%extrap that was very high (63%) and therefore was excluded.

The apparent total plasma clearance will be calculated as \[Dose/AUC0-inf\].

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=6 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of placebo.
The Apparent Total Plasma Clearance (CL) of Xisomab 3G3 After a Single Intravenous Injection Will be Calculated for Each Patient (Pharmacokinetic Outcome).
773.6 mL/hr
Standard Deviation 612.47
155.0 mL/hr
Standard Deviation 42.374
—

SECONDARY outcome

Timeframe: 14 days

Population: One subject (0.25 mg/kg xisomab 3G3) was excluded from the summary statistics since the 0.17 hr Xisomab 3G3 concentration was suspected to be an outlier. One subject (0.25 mg/kg xisomab 3G3) had an AUC%extrap that was very high (63%) and therefore was excluded.

The total apparent volume of distribution (Vss) will be calculated as the mean residence time x clearance.

Outcome measures

Outcome measures
Measure
AB023 (Xisomab 3G3)- Dose 1
n=6 Participants
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 Participants
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of placebo.
The Total Apparent Volume of Distribution (Vss) of Xisomab 3G3 After a Single Intravenous Injection Will be Calculated for Each Patient (Pharmacokinetic Outcome).
9945 mL
Standard Deviation 5014.8
5498 mL
Standard Deviation 793.78
—

Adverse Events

AB023 (Xisomab 3G3)- Dose 1

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

AB023 (Xisomab 3G3)- Dose 2

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
AB023 (Xisomab 3G3)- Dose 1
n=8 participants at risk
Participants will receive a single dose of 0.25 mg/kg xisomab 3G3. AB023- Dose 1: Participants will receive a single dose of 0.25 mg/kg AB023.
AB023 (Xisomab 3G3)- Dose 2
n=8 participants at risk
Participants will receive a single dose of 0.5 mg/kg xisomab 3G3. AB023-Dose 2: Participants will receive a single dose of 0.5 mg/kg AB023.
Placebo
n=8 participants at risk
Participants will receive a single dose of placebo. placebo: Participants will receive a single dose of placebo.
Infections and infestations
Viral gastroenteritis
25.0%
2/8 • Number of events 2 • Adverse event data was collected from study check in (Day -8) through the final follow up (Day 12) for a total of 21 days.
0.00%
0/8 • Adverse event data was collected from study check in (Day -8) through the final follow up (Day 12) for a total of 21 days.
12.5%
1/8 • Number of events 1 • Adverse event data was collected from study check in (Day -8) through the final follow up (Day 12) for a total of 21 days.

Additional Information

Christina U. Lorentz

Aronora, Inc.

Phone: 503-964-0250

Results disclosure agreements

  • Principal investigator is a sponsor employee Aronora, Inc. shall retain title to and the right to publish all documentation, records, raw data, specimens, or other work product generated in connection with this study. Such publications shall not be made by the PI or Celerion without the prior written consent of Aronora, Inc.
  • Publication restrictions are in place

Restriction type: OTHER