BioNTech SE
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.
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.…
Key Inclusion Criteria Part A: * Are HIV-1 and HIV-2 negative at Visit 0. * Starting at Visit 0 and continuously until the last planned visit in this study are individuals who: 1. Are assessed by the investigator as having a low likelihood of acquiring HIV and are committed to avoiding behaviors associated with a higher likelihood of acquiring HIV until the End of Study Visit. 2. Agree to discuss HIV disease risks; 3. Agree to HIV acquisition risk reduction counseling; Part B: * Are HIV-1 positive and HIV-2 negative at Visit 0. * Individuals who at Visit 0: 1. Are cART-naïve indi…
IV infusion
IV infusion
SC injection
SC injection