RecruitingPhase 1NCT07392372

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

Sponsor

BioNTech SE

Enrollment

61 participants

Start Date

Feb 9, 2026

Study Type

INTERVENTIONAL

Conditions

HIV-1-infection

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new antibody drug called BNT351 to see if it can help prevent HIV infection (in HIV-negative people) or improve immune control of HIV (in people already living with HIV). This is an early-phase safety and biological activity study. **You may be eligible if...** - You are HIV-negative and considered at low risk for acquiring HIV (Part A), OR - You have been recently diagnosed with HIV-1 (within the last 12 months) and either have never started HIV medication or recently stopped it (Part B) - You are willing to follow study procedures and attend all required visits **You may NOT be eligible if...** - You have HIV-2 infection (for Part A or B) - You have serious health conditions that would interfere with participation - You are pregnant or breastfeeding - You have a history of severe allergic reactions to injectable medications - You are currently using drugs that could interact with the study medication Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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