Phase 1 Study of BNT351 Antibody Safety and Activity in Adults With and Without HIV

What this Trial Is About

Researchers are evaluating the safety, blood levels, and antiviral activity of the antibody BNT351 in adults living with and without HIV. This Phase I study focuses on understanding any side effects of BNT351, measuring its concentration in the blood over time, and assessing its impact on HIV viral load in people living with HIV PLWH. The study includes both people without HIV and those with HIV who have detectable virus levels. The study has two parts. Part A involves people without HIV and uses a randomized, double-blind, placebo-controlled design with single ascending doses of BNT351 given either subcutaneously or intravenously across four cohorts. Part B includes people living with HIV and is an open-label, proof-of-concept study with two cohorts receiving a single dose of BNT351 followed by combination antiretroviral therapy cART starting about 56 days after dosing. Dosing progresses cautiously with sentinel participants and staggered dose escalation. Participants will undergo about a 4-week screening period before receiving one dose of BNT351 or placebo in Part A or BNT351 alone in Part B. Following dosing, Part A participants will be followed for approximately 38 weeks, totaling about 42 weeks in the study. Part B participants will have up to 8 weeks of observation with HIV viral load tests before starting cART, with overall follow-up lasting about 38 weeks post-dose. Safety, antibody levels, HIV viral load, immune cell counts, and potential side effects will be regularly monitored throughout the study.

A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIV