drugset / Trial / NCT06812494
A Study of VRC07-523LS, PGT121.414.LS, and PGDM1400LS Broadly Neutralizing Monoclonal Antibodies Given Intravenously in Adult Participants Without HIV
Phase 2
Recruiting
200 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Dale and Betty Bumpers Vaccine Research Center (VRC) · collabDepartment of Health and Human Services · collabNational Institutes of Health (NIH) · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
HVTN 206/HPTN 114 is a randomized, double blind, controlled, phase 2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and neutralization of VRC07-523LS, PGT121.414.LS, and PGDM1400LS broadly neutralizing monoclonal antibodies given intravenously in adult participants without HIV. The hypothesis of the study is that the combination of VRC07-523LS and PGT121.414.LS and PGDM1400LS antibodies when administered via the intravenous (IV) route will be safe and tolerable in adult participants without HIV. The study aims to enroll 200 participants across multiple sites with an estimated total duration of participation of eighteen (18) months.
Timeline
- Start
- 2025-03-07
- Primary completion
- 2027-01-15
- Completion
- 2027-09-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PGDM1400LS | Monoclonal antibody | 400 mg | Intravenous |
| Subject | PGDM1400LS | Monoclonal antibody | 1600 mg | Intravenous |
| Subject | PGT121.414.LS | Monoclonal antibody | 400 mg | Intravenous |
| Subject | PGT121.414.LS | Monoclonal antibody | 1600 mg | Intravenous |
| Subject | VRC07-523LS | Monoclonal antibody | 400 mg | Intravenous |
| Subject | VRC07-523LS | Monoclonal antibody | 3200 mg | Intravenous |