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

NCT07392372 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2026-03-19

No results posted yet for this study

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.

Conditions

  • HIV -1 Infection

Interventions

DRUG

BNT351

IV infusion

DRUG

Placebo

IV infusion

DRUG

BNT351

SC injection

DRUG

Placebo

SC injection

Sponsors & Collaborators

Principal Investigators

  • BioNTech Response Person · BioNTech SE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-09
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States
  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07392372 on ClinicalTrials.gov