NCT05959707

Evaluating the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibodies in Healthy Participants

A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibodies VRC01.23LS, PGT121.414.LS and PGDM1400LS Administered Via Intravenous Infusion in Adults Without HIV

• Status: Suspended
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 77 (estimated)
• Sponsor: HIV Vaccine Trials Network · Network
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Part A: The purpose of this part is to study how the body's immune system reacts to a lab-made HIV-1 monoclonal antibody against HIV antigen when given in different doses. The study will also evaluate if the antibody is safe to give to people and does not make them too uncomfortable. Part B: The purpose of this part is to study how the body's immune system reacts to a combination of lab-made HIV-1 monoclonal antibodies against HIV antigens when given in different doses. The study also wants to see if the way the antibodies are given affects the immune response.

Detailed description

This study aims to evaluate the safety, tolerability, dose, and PK of VRC01.23LS administered IV and in combination with PGDM1400LS, a V2-apex-targeting mAb, and PGT121.414.LS, a V3-glycan-targeting mAb. There are 2 parts to this study: Part A and Part B. In Part A, 15 participants will be randomly assigned to test one study antibody at different doses. After we see the results from Part A, we will decide whether or not to do Part B of the study. In Part B, 62 participants will be randomly assigned to test a combination of 3 study antibodies, including the one tested in Part A.

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	VRC01.23LS	VRC01.23LS will be administered IV over approximately 30 to 60 minutes.
BIOLOGICAL	PGT121.414.LS	PGT121.414.LS will be administered IV over approximately 30 to 60 minutes.
BIOLOGICAL	PGDM1400LS	PGDM1400LS will be administered IV over approximately 30 to 60 minutes.

Timeline

• Start date: 2024-08-14
• Primary completion: 2025-01-14
• Completion: 2025-01-14
• First posted: 2023-07-25
• Last updated: 2024-07-05

Locations

8 sites across 1 country: South Africa