HVTN 140/HPTN 101

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 Summary

Study Details

Protocol Status: Enrolling
Study Purpose:
Study Design:

Multicenter, randomized, open-label study

Study Population:

About 95 healthy, HIV-1–uninfected volunteers aged 18 through 50 years

Study Size:

95 participants

Study Duration:
Treatment Regimen:
Primary Objectives:

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)