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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
BioNTech SE
Study ID
NCT07392372
Phase
PHASE1
Status
Recruiting
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Conditions

  • HIV -1 Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • BNT351 — DRUG
    IV infusion
  • Placebo — DRUG
    IV infusion
  • BNT351 — DRUG
    SC injection
  • Placebo — DRUG
    SC injection

Study Details

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.

Key Dates

Start date
Feb 9, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
61 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A - Cohort A1
    PLWOH will be randomized to BNT351 (at a protocol defined dose level) or placebo (2:1)
  • Experimental: Part A - Cohort A2
    PLWOH will be randomized to BNT351 (at a protocol defined dose level) or placebo (3:1)
  • Experimental: Part A - Cohort A3
    PLWOH will be randomized to BNT351 (at a protocol defined dose level) or placebo (3:1)
  • Experimental: Part A - Cohort A4
    PLWOH will be randomized to BNT351 (at a protocol defined dose level) or placebo (3:1)
  • Experimental: Part B - Cohort B1
    PLWH will receive BNT351 at a protocol-defined dose level. cART will start 56 days post-BNT351 dosing or earlier.

Primary Outcome Measure

Parts A and B - Occurrence of at least one adverse event (AE) [ Time Frame: From dosing to 56 days post-dose ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns HopkinsBaltimoreMaryland21205-1832-

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By research site
Johns Hopkins· Baltimore, MD

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