Safety, PK and Antiviral Activity of PGT121 Monoclonal Antibody in HIV-uninfected and HIV-infected Adults

Phase 1 Completed 48 enrolled International AIDS Vaccine Initiative Beth Israel Deaconess Medical Center · collab Mills Clinical Research, Los Angeles CA · collab Orlando Immunology Clinic, Orlando FL · collab Ragon Institute of MGH, MIT and Harvard, Boston MA · collab University of Texas Health, Houston AIDS Research Team (HART), Houston TX · collab

RandomizedParallel-groupDouble-blindPrevention

Summary

This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and anti-viral efficacy of the PGT121 monoclonal antibody for HIV prevention and therapy.

Timeline

Start: 2016-11
Primary completion: 2019-07-08
Completion: 2019-07-08

Publications

Stephenson KE, Julg B, Tan CS, Zash R, Walsh SR, Rolle CP, Monczor AN, Lupo S, Gelderblom HC, Ansel JL, Kanjilal DG, Maxfield LF, Nkolola J, Borducchi EN, Abbink P, Liu J, Peter L, Chandrashekar A, Nityanandam R, Lin Z, Setaro A, Sapiente J, Chen Z, Sunner L, Cassidy T, Bennett C, Sato A, Mayer B, Perelson AS, deCamp A, Priddy FH, Wagh K, Giorgi EE, Yates NL, Arduino RC, DeJesus E, Tomaras GD, Seaman MS, Korber B, Barouch DH. Safety, pharmacokinetics and antiviral activity of PGT121, a broadly neutralizing monoclonal antibody against HIV-1: a randomized, placebo-controlled, phase 1 clinical trial. Nat Med. 2021 Oct;27(10):1718-1724. doi: 10.1038/s41591-021-01509-0. Epub 2021 Oct 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PGT121	Monoclonal antibody	3 mg/kg	Intravenous
Subject	PGT121	Monoclonal antibody	10 mg/kg	Intravenous
Subject	PGT121	Monoclonal antibody	30 mg/kg	Intravenous

Safety, PK and Antiviral Activity of PGT121 Monoclonal Antibody in HIV-uninfected and HIV-infected Adults

Summary

Timeline

Publications

Drugs

Indications