At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 43 enrolled
Drug / intervention
AB103 +1 moredrug
Likely dose
AB103 0.25 mg/kgfrom 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.
Evaluation of Safety, Pharmacokinetics and Immunomodulatory Effects of AB103, a CD28 Co-stimulatory Receptor Antagonist, in Patients Diagnosed With Necrotizing Soft Tissue Infections
In Brief
A Phase 2 clinical trial evaluating AB103 and Placebo for Necrotizing Soft Tissue Infections. Completed, enrolled 43 participants across 7 sites.
Detailed Summary
A study to evaluate the safety and pharmacokinetics profile of different doses of AB103 administered to patients diagnosed with Necrotizing Soft Tissue Infections that are scheduled for an urgent surgical intervention as part of their standard of care.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNecrotizing Soft Tissue Infections
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 2011
Enrollment StartDec 2011
Primary CompletionSep 2012
TodayJul 2026
First PostedAug 16, 2011
Enrollment StartDec 1, 2011
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 14.9 years ago
Interventions
AB103drug
AB103 0.25 mg/kg or 0.5 mg/kg administered as a single IV infusion
Placebodrug
Normal saline (0.9% sodium chloride) administered as a single IV infusion