At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 25 enrolled
Drug / intervention
AB103 +1 moredrug
Likely dose
AB103 7.5 µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 1, Double Blind, Placebo-Controlled, Dose Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Clinical Trial of AB103, A Peptide Antagonist in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating AB103 and Placebo for Healthy Volunteer Safety Study. Completed, enrolled 25 participants across 1 site.
Detailed Summary
The primary objective of this study is to establish the safety profile and maximum tolerated dose (MTD) of AB103 given as a single intravenous (IV) infusion in healthy volunteers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteer Safety Study
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 2010
Enrollment StartSep 2010
Primary CompletionJun 2011
TodayJul 2026
First PostedJul 21, 2010
Enrollment StartSep 1, 2010
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 15.9 years ago
Interventions
AB103drug
Single intravenous infusion at doses of 7.5 µg/kg, 37.5 µg/kg, 150 µg/kg, or 450 µg/kg administered over approximately 10 minutes
Placebodrug
Single intravenous infusion of normal saline (0.9% sodium chloride) administered over approximately 10 minutes