At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 124 enrolled
Drug / intervention
VRC07-523LS +1 morebiological
Likely dose
Not stated in 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.
A Multicenter, Randomized, Partially Blinded Phase 1 Clinical Trial to Evaluate the Safety and Serum Concentrations of a Human Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered in Multiple Doses and Routes to Healthy, HIV-uninfected Adults
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Dec 29, 2017·Updated Apr 5, 2023
In Brief
A Phase 1 clinical trial evaluating VRC07-523LS and Placebo for HIV Infections. Completed, enrolled 124 participants across 7 sites in 2 countries.
Detailed Summary
The purpose of this study is to evaluate the safety, tolerability, and serum concentrations of a human monoclonal antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), administered in multiple doses and routes to healthy, HIV-uninfected adults.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesSwitzerland, United States
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedDec 2017
Enrollment StartFeb 2018
Primary CompletionDec 2020
TodayJul 2026
First PostedDec 29, 2017
Enrollment StartFeb 28, 2018
Primary CompletionDec 7, 2020
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 8.5 years ago
Interventions
VRC07-523LSbiological
Administered by intravenous (IV) infusion, subcutaneous (SC) injection, or intramuscular (IM) injection, depending on which group participants are in
Placebobiological
Sodium Chloride for Injection USP, 0.9%; administered by IM injection