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.
Research Team
B
BioNTech clinical trials patient information
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here