NCT07392372

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

A Phase I First-in-human Clinical Trial to Evaluate the Safety, Pharmacokinetics, and Antiviral Activity of the Broadly Neutralizing Antibody BNT351 in Adults Living Without and With HIV

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (estimated)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will test the safety and blood levels of the antibody BNT351 in people living without and with human immunodeficiency virus (HIV). This study will also test the anti-viral activity of BNT351 in people living with HIV (PLWH) with detectable virus levels. The main goals of this study are: * To learn about the safety of BNT351 and check for side effects. * To measure the amount of BNT351 antibody in blood over time. * To test the amount of HIV in the blood at different times after treatment with BNT351 in people living with HIV.

Detailed description

The study will consist of two parts (Parts A and B). Part A will be a randomized, double-blind, placebo-controlled, single ascending dose, first-in-human study part. Part A will enroll people living without HIV (PLWOH). Four cohorts are planned in Part A (Cohorts A1, A2, A3, and A4). Cohort A1 will evaluate one dose of BNT351 administered subcutaneously (SC). Cohorts A2 to A4 will evaluate three different doses of BNT351 administered intravenously (IV). For each cohort, participants will be randomized to BNT351 or placebo. Part B will be single-dose, open-label, proof-of concept study part. Part B will enroll PLWH. Part B comprises of a single cohort (Cohort B1) and will be non-randomized. The study will start with recruitment into Part A. Part B will be opened after review of safety data from Part A. In Part A, for each participant, there will be an \~4-week screening period, one dose of BNT351 or placebo, and an \~38-week follow-up period. In total, Part A will last up to \~42 weeks per participant. In Part B, for each participant, there will be an \~4-week screening period, one dose of BNT351, and an up to 8-week observation period with HIV viral load assessments, after which combination antiretroviral therapy (cART) will be started. Overall, participants will be followed for \~38 weeks after IMP administration and in total, Part B will last up to \~42 weeks per participant.

Conditions

• HIV -1 Infection

Interventions

Type	Name	Description
DRUG	BNT351	IV infusion
DRUG	Placebo	IV infusion
DRUG	BNT351	SC injection
DRUG	Placebo	SC injection

Timeline

• Start date: 2026-02-09
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2026-02-06
• Last updated: 2026-03-19

Locations

3 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study