A Study of Safety and Drug Levels of ePGT121v1-LS, PGDM1400LS, and VRC07-523LS in Adult Participants Without HIV-1
Phase 1
18–55
8 sites in AL, CA, DC +5
What this study is about
This Phase 1 study is focused on people with hiv. The primary outcome being measured is Part A: AUC of PGDM1400LS.
Simplified from trial records by PatientMatch.
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Assignment is predetermined by the study protocol.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
infusion, subcutaneous
Primary: Part A: AUC of PGDM1400LS, Part A: AUC of VRC07-523LS, Part A: Area Under the Concentration-Time Curve (AUC) of ePGT121v1-LS, Part A: Area Under the Magnitude-Breadth Curve (AUC-MB), Part A: Clearance (CL) of ePGT121v1-LS, Part A: Cmax of PGDM1400LS, Part A: Cmax of VRC07-523LS, Part A: Maximum Observed Concentration (Cmax) of ePGT121v1-LS
Secondary: Area Under the Magnitude-Breadth Curve (AUC-MB), Correlation Between Serum/Plasma Concentration and AUC-MB of Serum Neutralization Across the Virus Panel, Population pharmacokinetic (PopPK) modeling of monoclonal antibody (mAb) concentration-time data
Immune, Infectious