drugset / Trial / NCT06517693
Safety and Pharmacokinetics Study of PGT121.414.LS Alone and in Combination With VRC07-523LS in Infants Exposed to HIV-1
Phase 1
Recruiting
48 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabNational Institute of Mental Health (NIMH) · collab
Non-randomizedSequentialOpen-labelPrevention
Summary
The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of the potent, broadly neutralizing anti-HIV monoclonal antibodies (mAb) PGT121.414.LS alone and in combination with VRC07-523LS soon after birth in infants exposed to HIV-1.
Timeline
- Start
- 2026-01-05
- Primary completion
- 2027-12-31
- Completion
- 2028-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PGT121.414.LS | Monoclonal antibody | 100 mg | Subcutaneous |
| Subject | VRC07-523LS | Monoclonal antibody | 100 mg | Subcutaneous |
Indications
No indication recorded.