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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

NCT03387150 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2023-04-05

Study results available
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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.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

VRC07-523LS

Administered by intravenous (IV) infusion, subcutaneous (SC) injection, or intramuscular (IM) injection, depending on which group participants are in

BIOLOGICAL

Placebo

Sodium Chloride for Injection USP, 0.9%; administered by IM injection

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Stephen Walsh · Brigham and Women's Hospital

  • Cynthia Gay · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-02-28
Primary Completion
2020-12-07
Completion
2020-12-07
FDA Drug
Yes

Countries

  • United States
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03387150 on ClinicalTrials.gov