Actively Recruiting
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
Led by BioNTech SE · Updated on 2026-03-19
61
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, blood levels, and antiviral effects of the antibody BNT351 in adults living with and without HIV. This Phase 1 clinical trial aims to understand how BNT351 behaves in the body and how it affects HIV levels in people living with HIV. It includes a first-in-human randomized, double-blind, placebo-controlled phase for people without HIV and an open-label proof-of-concept phase for people with HIV.
CONDITIONS
Brief Title
A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For Part A: HIV-1 and HIV-2 negative at screening.
- For Part A: Low risk of acquiring HIV and committed to avoiding high-risk behaviors until study end.
- For Part A: Willing to discuss HIV risks and receive HIV risk reduction counseling.
- For Part B: HIV-1 positive and HIV-2 negative at screening.
- For Part B: Newly diagnosed or recently discontinued combination antiretroviral therapy (cART) as defined.
- For Part B: No prior lenacapavir or recent long-acting ART treatments.
- For Part B: CD4+ T cell count ≥400 cells/µL and HIV-1 RNA 1,000-100,000 copies/mL at screening.
- For Part B: Willing to start cART at a defined time and maintain low-risk behavior with counseling.
You will not qualify if you...
- For Part A: Previous HIV vaccination or broadly neutralizing antibody use in clinical studies.
- For Part A: Known or suspected immune impairments or recent immunosuppressive treatments (with some corticosteroid exceptions).
- For Part A: History of severe allergic reactions to human or humanized antibodies or BNT351 components.
- For Part B: Previous HIV vaccination or broadly neutralizing antibody use in clinical studies.
- For Part B: Current treatment for tuberculosis infection.
- For Part B: History of opportunistic infections or AIDS-defining illnesses.
- For Part B: Multi-class drug resistant HIV-1 infection history.
- For Part B: History of malignancy within 5 years, except certain skin or cervical cancers.
- For Part B: Known or suspected immune impairments or recent immunosuppressive treatments (with some corticosteroid exceptions).
- For Part B: History of severe allergic reactions to human or humanized antibodies or BNT351 components.
- Other protocol-defined criteria may also apply.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Approximately 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single dose day
Participants receive a single dose of the antibody BNT351 or placebo administered either subcutaneously or intravenously.
1 dosing visit (in-person)
Duration - Up to 38 weeks after dosing
Participants are monitored for safety, biological activity, and adverse events following dosing. Participants living without HIV are followed for up to 38 weeks. Participants living with HIV are observed for up to 8 weeks with HIV viral load assessments before starting combination antiretroviral therapy (cART), then followed up to a total of approximately 38 weeks.
Multiple visits including scheduled HIV viral load assessments for participants living with HIV
Trial Site Locations
Total: 3 locations
1
Johns Hopkins
Baltimore, Maryland, United States, 21205-1832
Actively Recruiting
2
UK Köln
Cologne, Germany, 50937
Not Yet Recruiting
3
CRS Mannheim
Mannheim, Germany, 68167
Actively Recruiting
Research Team
B
BioNTech clinical trials patient information
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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