NCT02960581

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

A Phase 1 Randomized Placebo-controlled Clinical Trial of the Safety, Pharmacokinetics and Antiviral Activity of PGT121 Monoclonal Antibody (mAb) in HIV-uninfected and HIV-infected Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: International AIDS Vaccine Initiative · Network
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. PGT121 mAb is a recombinant human IgG1 monoclonal antibody that targets a V3 glycan-dependent epitope region of the HIV envelope protein. PGT121 mAb was chosen for this study because it is potent, neutralizes a wide array of HIV viruses, and can prevent and treat simian-human immunodeficiency virus (SHIV) in rhesus monkeys.

Conditions

• HIV Infection

Interventions

Type	Name	Description
BIOLOGICAL	PGT121 3mg/kg IV	3mg/kg administered by IV Infusion
BIOLOGICAL	PGT121 10mg/kg IV	10mg/kg administered by IV infusion
BIOLOGICAL	PGT121 30mg/kg IV	30mg/kg administered by IV infusion
BIOLOGICAL	PGT121 3mg/kg SC	3mg/kg administered by SC injection Placebo: None
BIOLOGICAL	Placebo (0.9% Sodium Chloride Injection USP (Saline))

Timeline

• Start date: 2016-11-01
• Primary completion: 2019-07-08
• Completion: 2019-07-08
• First posted: 2016-11-09
• Last updated: 2019-09-17

Locations

1 site across 1 country: United States