drugset / Trial / NCT04173819
Safety and Pharmacokinetics of the Combination Broadly Neutralizing Antibodies, 3BNC117-LS-J and 10-1074-LS-J, in Healthy American and African Adults
Phase 1/2
Completed
225 enrolled
International AIDS Vaccine Initiative
Brigham and Women's Hospital · collabFred Hutchinson Cancer Center · collabRockefeller University · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
This is a Phase 1/2 study to evaluate the safety, tolerability, and pharmacokinetics of two broadly neutralizing monoclonal human antibodies (bNAbs), 3BNC117-LS-J, which targets the CD4 binding site on HIV-1 envelope protein, and 10-1074-LS-J which targets the V3 loop of HIV-1 envelope protein. The hypothesis is that the two antibodies will be safe for healthy HIV-1 uninfected adults when co-administered subcutaneously or intravenously and, after subcutaneous administration in the optimal ratio, each antibody will maintain serum levels \>10 µg/ml for at least 3 months in HIV-uninfected participants.
Timeline
- Start
- 2019-01-25
- Primary completion
- 2023-09-01
- Completion
- 2023-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 10-1074-LS-J | Monoclonal antibody | 30 mg/kg | Subcutaneous |
| Subject | 10-1074-LS-J | Monoclonal antibody | 300 mg | Subcutaneous |
| Subject | Teropavimab | Monoclonal antibody | 30 mg/kg | Subcutaneous |
| Subject | Teropavimab | Monoclonal antibody | 300 mg | Subcutaneous |