HVTN 136/HPTN 092

A phase 1 dose-escalation clinical trial to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of the monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS via intravenous infusion or via subcutaneous injections in healthy, HIV-uninfected adult participants.

Study Details

Protocol Status: Enrolling
Study Purpose:

A phase 1 dose-escalation clinical trial to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of the monoclonal antibody PGT121.414.LS administered alone and in combination with VRC07-523LS via intravenous infusion or via
subcutaneous injections in healthy, HIV-uninfected adult participants

Study Design:

Multicenter design. Part A: dose escalation, first in human, open-label IV or SC product administration with randomization into Groups 3 and 4; Part B: randomized, open-label IV or SC product administration

Study Population:

32 healthy, HIV-1–uninfected volunteers aged 18 to 50 years in the United States

Study Size:

32 healthy, HIV-1–uninfected volunteers aged 18 to 50 years

Study Duration:

Part A: 8 months per participant in Groups 1, 2 and 3; 6 months per participant in Group 4; 16 months per participant in Part B. 24 months (includes enrollment, planned safety holds, and follow-up)

Treatment Regimen:
Primary Objectives:

Primary objective 1
To evaluate the safety and tolerability of the PGT121.414.LS monoclonal antibody (mAb) when administered alone via intravenous (IV) infusion or subcutaneous (SC) injections (Part A) and of PGT121.414.LS and VRC07-523LS administered consecutively via IV or SC routes at and after each product administration visit (Part B).
Primary objective 2
To evaluate the serum concentrations and pharmacokinetic (PK) properties of PGT121.414.LS after a single administration (Part A) and of PGT121.414.LS and VRC07-523LS after consecutive administration of the pair of mAbs at and after each of 3 quarterly visits (Part B).
Primary objective 3
To evaluate the individual mAb-specific serum neutralizing activity of
PGT121.414.LS after a single administration (Part A) and of PGT121.414.LS and VRC07-523LS after consecutive administration of the pair of mAbs at and after each of 3 quarterly visits (Part B).