Phase 1 Trial to Assess Safety and Drug Levels of ePGT121v1-LS, PGDM1400LS, and VRC07-523LS Given by IV or SC to Adults Without HIV-1 Aged 18 to 55

What this Trial Is About

Researchers are evaluating a lab-made antibody called ePGT121v1-LS designed to target a specific part of HIV. This Phase 1 clinical trial also studies this antibody alone and in combination with two other antibodies, VRC07-523LS and PGDM1400LS, which target different parts of the virus. The study aims to assess the safety, side effects, proper dosing, how the body processes these antibodies, and their ability to neutralize HIV in the blood. The trial includes about 83 generally healthy adults without HIV-1, aged 18 to 55. Participants are divided into two parts. In Part A, six groups receive ePGT121v1-LS by intravenous IV infusion at various doses, either alone or combined with the other two antibodies, given at two visits 24 weeks apart over 48 weeks. In Part B, two groups receive subcutaneous SC injections either of ePGT121v1-LS alone or combined with the other antibodies, given at two visits 12 weeks apart over 24 weeks. Each dose and administration schedule is carefully studied in these groups. Throughout the study, participants attend scheduled clinic visits for up to 48 weeks depending on their group. They will be monitored for local and systemic side effects, laboratory safety tests, and the levels of antibodies in their blood. Researchers will track how the antibodies are absorbed, distributed, and cleared, along with their neutralizing activity against HIV. Safety, tolerability, and antibody interactions are key outcomes during the follow-up period.

A Study of Safety and Drug Levels of ePGT121v1-LS, PGDM1400LS, and VRC07-523LS in Adult Participants Without HIV-1