A phase 1 dose-escalation clinical trial to evaluate the safety, tolerability, and pharmacokinetics of PGDM1400LS alone and in combination with VRC07-523LS and PGT121.414.LS in healthy, HIV-uninfected adult participants
Study Documents
- HVTN 140/HPTN 101 Protocol V1.0 - 23 June 2021
- Frequently Asked Questions
Study Details
Multicenter, randomized, open-label study
About 95 healthy, HIV-1–uninfected volunteers aged 18 through 50 years
95 participants
To evaluate the safety and tolerability of PGDM1400LSwhen administered via intravenous (IV) or subcutaneous (SC) routes (Part A) and of PGDM1400LS+ VRC07-523LS + PGT121.414.LS when administered in sequence IV or SC (Part B)•To evaluate the serum concentrations and pharmacokinetics of PGDM1400LS after a single administration (Part A) and of PGDM1400LS + VRC07-523LS + PGT121.414.LS after each three-mAb administration (Part B)