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NCT03387150 · ClinicalTrials.gov registry record · Phase 1

Evaluating 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

A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
124
Enrollment target

NCT03387150: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT03387150 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 124 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (107% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03387150, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
124 participants
Enrollment target

Study 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.

Primary Outcome

Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL VRC07-523LS

Trial Details

FieldValue
Enrollment Target 124 participants
Start Date 2018-02-28
Est. Completion 2020-12-07
Phase Phase 1

What the finished NCT03387150 record still lists

NCT03387150 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (107% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03387150 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03387150 about?

NCT03387150 is a clinical study titled "Evaluating 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". 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.

What is the current status of trial NCT03387150?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 124 participants. The study started on 2018-02-28. Estimated completion is 2020-12-07.

What interventions are being tested in trial NCT03387150?

The interventions under investigation include: Placebo (BIOLOGICAL), VRC07-523LS (BIOLOGICAL).

Who is sponsoring clinical trial NCT03387150?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03387150's enrollment target sits among peer trials

124 471st of 2000 higher than 1,526 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03387150, the US trial registry maintained by the National Library of Medicine. NCT03387150 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.