Trial Outcomes & Findings for AB103 Peptide Antagonist in Healthy Volunteers (NCT NCT01166984)

Last Updated: 2021-06-09

Results Overview

An AE is any untoward medical occurrence in a subject administered study drug and that does not necessarily have a causal relationship with the study drug. An AE could therefore be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the study drug.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

25 participants

Primary outcome timeframe

2 weeks

Results posted on

2021-06-09

Participant Flow

Subjects were recruited at the University of Maryland School of Medicine starting 7 September 2010. The study concluded 10 April 2011.

One consented and screened subject found to be eligible was not randomized into the study because the target number of subjects had already been achieved.

Participant milestones

Participant milestones
Measure	AB103 7.5 µg/kg AB103 7.5 µg/kg single IV infusion	AB103 37.5 µg/kg AB103 37.5 µg/kg single IV infusion	AB103 150 µg/kg AB103 150 µg/kg single IV infusion	AB103 450 µg/kg AB103 450 µg/kg single IV infusion	Placebo Normal saline (0.9% sodium chloride) single IV infusion
Overall Study STARTED	5	5	5	5	5
Overall Study COMPLETED	5	5	5	5	5
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

AB103 Peptide Antagonist in Healthy Volunteers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AB103 7.5 µg/kg n=5 Participants AB103 7.5 µg/kg administered as a single IV infusion	AB103 37.5 µg/kg n=5 Participants AB103 37.5 µg/kg administered as a single IV infusion	AB103 150 µg/kg n=5 Participants AB103 150 µg/kg administered as a single IV infusion	AB103 450 µg/kg n=5 Participants AB103 450 µg/kg administered as a single IV infusion	Placebo n=5 Participants Normal saline (0.9% sodium chloride) administered as a single IV infusion	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	25 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Continuous	28 years STANDARD_DEVIATION 7 • n=5 Participants	29 years STANDARD_DEVIATION 6 • n=7 Participants	34 years STANDARD_DEVIATION 5 • n=5 Participants	30 years STANDARD_DEVIATION 4 • n=4 Participants	30 years STANDARD_DEVIATION 8 • n=21 Participants	30 years STANDARD_DEVIATION 6 • n=8 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	8 Participants n=8 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	17 Participants n=8 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	5 participants n=5 Participants	5 participants n=4 Participants	5 participants n=21 Participants	25 participants n=8 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: The analysis population consisted of all subjects who received a dose of study drug.

Outcome measures

Outcome measures
Measure	AB103 7.5 µg/kg n=5 Participants Each subject received a single IV infusion of AB103 7.5 µg/kg	AB103 37.5 µg/kg n=5 Participants Each subject received a single IV infusion of AB103 37.5 µg/kg	AB103 150 µg/kg n=5 Participants Each subject received a single IV infusion of 150 µg/kg	AB103 450 µg/kg n=5 Participants Each subject received a single IV infusion of 450 µg/kg	Placebo n=5 Participants Each subject received a single IV infusion of normal saline (0.9% sodium chloride)
Number Adverse Events (AEs)	7 adverse events	2 adverse events	1 adverse events	9 adverse events	3 adverse events

PRIMARY outcome

Timeframe: 2 weeks

Population: The analysis population consisted of all subjects receiving a dose of study drug.

A serious adverse event (SAE) is an AE occurring during any study phase and at any dose of the study drug (AB103 or placebo) that fulfills one or more of the following criteria: * Results in death * Is life-threatening (i.e., the subject was, in the opinion of the Investigator, at immediate risk of death from the event as it occurred) * Requires or prolongs hospitalization * Results in persistent or significant disability or incapacity (i.e., the event causes a substantial disruption of a person's ability to conduct normal life functions) * Is a congenital anomaly or birth defect, or * Is an important and significant medical event.

Outcome measures

Outcome measures
Measure	AB103 7.5 µg/kg n=5 Participants Each subject received a single IV infusion of AB103 7.5 µg/kg	AB103 37.5 µg/kg n=5 Participants Each subject received a single IV infusion of AB103 37.5 µg/kg	AB103 150 µg/kg n=5 Participants Each subject received a single IV infusion of 150 µg/kg	AB103 450 µg/kg n=5 Participants Each subject received a single IV infusion of 450 µg/kg	Placebo n=5 Participants Each subject received a single IV infusion of normal saline (0.9% sodium chloride)
Number of Serious Adverse Events (SAEs)	0 serious adverse events	0 serious adverse events	0 serious adverse events	0 serious adverse events	0 serious adverse events

PRIMARY outcome

Timeframe: 2 weeks

DLTs were defined as the emergence of one or more selected AEs that reached a threshold that may justify stopping the trial.

Outcome measures

Outcome measures
Measure	AB103 7.5 µg/kg n=5 Participants Each subject received a single IV infusion of AB103 7.5 µg/kg	AB103 37.5 µg/kg n=5 Participants Each subject received a single IV infusion of AB103 37.5 µg/kg	AB103 150 µg/kg n=5 Participants Each subject received a single IV infusion of 150 µg/kg	AB103 450 µg/kg n=5 Participants Each subject received a single IV infusion of 450 µg/kg	Placebo n=5 Participants Each subject received a single IV infusion of normal saline (0.9% sodium chloride)
Number of Dose-limiting Toxicities (DLTs)	0 DLTs	0 DLTs	0 DLTs	0 DLTs	0 DLTs

SECONDARY outcome

Timeframe: Whole blood was collected pre-dose; at the mid-point of the infusion; at 1, 2, 5, 10, 20, 30, and 60 minutes post-infusion; and at approximately 24 hours post-infusion for the measurement of AB103 plasma concentrations.

Population: AUC could not be determined in the AB103 7.5 µg/kg group and the placebo group because of the number of plasma concentration results that were undetectable.

Area under the plasma concentration-time curve (AUC) from time zero to infinity following a single dose of study drug, obtained via noncompartmental methods. It is an integrated measure of study drug plasma exposure.

Outcome measures

Outcome measures
Measure	AB103 7.5 µg/kg n=5 Participants Each subject received a single IV infusion of AB103 7.5 µg/kg	AB103 37.5 µg/kg n=5 Participants Each subject received a single IV infusion of AB103 37.5 µg/kg	AB103 150 µg/kg n=5 Participants Each subject received a single IV infusion of 150 µg/kg	AB103 450 µg/kg Each subject received a single IV infusion of 450 µg/kg	Placebo Each subject received a single IV infusion of normal saline (0.9% sodium chloride)
Area Under the Plasma Concentration-time Curve (AUC)	527 ng*min/mL Interval 238.0 to 911.0	2085 ng*min/mL Interval 1740.0 to 2743.0	5831 ng*min/mL Interval 4214.0 to 9441.0	—	—

SECONDARY outcome

Population: Cmax is not available (applicable) to placebo patients (no detectable plasma concentrations).

Maximum plasma concentration

Outcome measures

Outcome measures
Measure	AB103 7.5 µg/kg n=5 Participants Each subject received a single IV infusion of AB103 7.5 µg/kg	AB103 37.5 µg/kg n=5 Participants Each subject received a single IV infusion of AB103 37.5 µg/kg	AB103 150 µg/kg n=5 Participants Each subject received a single IV infusion of 150 µg/kg	AB103 450 µg/kg n=5 Participants Each subject received a single IV infusion of 450 µg/kg	Placebo Each subject received a single IV infusion of normal saline (0.9% sodium chloride)
Cmax	10.63 ng/mL Interval 7.35 to 11.97	52.67 ng/mL Interval 19.99 to 104.35	190.90 ng/mL Interval 160.77 to 295.21	611.19 ng/mL Interval 455.36 to 1031.71	—

SECONDARY outcome

Population: This outcome measure could not be determined in the 7.5 µg/kg dose group because of the frequency of undetectable plasma concentrations. It was not determined for placebo subjects (undetectable plasma concentrations).

Apparent terminal plasma half-life (T1/2) is the amount of time for plasma concentrations to decline by 50%.

Outcome measures

Outcome measures
Measure	AB103 7.5 µg/kg n=5 Participants Each subject received a single IV infusion of AB103 7.5 µg/kg	AB103 37.5 µg/kg n=5 Participants Each subject received a single IV infusion of AB103 37.5 µg/kg	AB103 150 µg/kg n=5 Participants Each subject received a single IV infusion of 150 µg/kg	AB103 450 µg/kg Each subject received a single IV infusion of 450 µg/kg	Placebo Each subject received a single IV infusion of normal saline (0.9% sodium chloride)
Apparent Terminal Plasma Half-life (T1/2)	1.42 hours (h) Interval 0.78 to 1.83	1.36 hours (h) Interval 0.77 to 1.48	1.28 hours (h) Interval 1.16 to 1.67	—	—

SECONDARY outcome

Population: Clearance was not determined in the 7.5 µg/kg dose group because of the frequency of undetectable AB103 plasma concentrations. Clearance was not determined in the placebo group (undetectable plasma concentrations).

Clearance (CL) is the volume of plasma completely cleared of drug per unit of time.