NCT03735849

Evaluating the Safety and Pharmacokinetics of VRC07-523LS in the Sera and Mucosae of Healthy, HIV-Uninfected Adult Participants

A Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetics of VRC-HIVMAB075-00-AB (VRC07-523LS) in the Sera and Mucosae of Healthy, HIV-1-Uninfected Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and pharmacokinetics of a human monoclonal antibody (VRC07-523LS) in the sera and mucosae of healthy, HIV-uninfected adults.

Detailed description

This study will evaluate the safety and pharmacokinetics of a human monoclonal antibody (VRC07-523LS) in the sera and mucosae of healthy, HIV-uninfected adults. Participants will be randomly assigned to one of two groups. Participants in Group 1 will receive 10 mg/kg of VRC07-523LS at Weeks 0, 16, and 32. Participants in Group 2 will receive 30 mg/kg of VRC07-523LS at Weeks 0, 16, and 32. Study visits will occur at Weeks 0, 2, 16, 18, 32, 34, and 48. Visits may include physical examinations; blood and urine collection; rectal, cervicovaginal, and seminal secretion collection; cervical, rectal, and vaginal biopsy collection; HIV testing; risk reduction counseling; and questionnaires. Study staff will contact participants at Week 50 for follow-up safety monitoring.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	VRC07-523LS	Administered by intravenous (IV) infusion

Timeline

• Start date: 2019-01-18
• Primary completion: 2020-12-21
• Completion: 2020-12-21
• First posted: 2018-11-08
• Last updated: 2025-06-05
• Results posted: 2022-03-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study