HVTN 129/HPTN 088

A phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and functional activity of a trispecific antibody, SAR441236, in healthy, HIV-1–uninfected adult participants

Study Summary

Protocol Status: In Development

Study Details

Protocol Status: In Development
Study Purpose:

A phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and functional activity of a trispecific antibody, SAR441236, in healthy, HIV-1–uninfected adult participants

Study Design:

Multicenter trial that is open label in part A and randomized, placebo-controlled, and double-blinded in part B

Study Population:

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

Study Size:

78 healthy, HIV-1–uninfected volunteers aged 18 to 50 years (70 study product recipients, 8 control recipients)

Study Duration:

~6 months of scheduled clinic visits for Groups 1-5 and ~17 months for Groups 6-7
30 months total study duration (includes enrollment, planned safety holds, and follow-up)

Treatment Regimen:
Primary Objectives:

1. To evaluate the safety and tolerability of SAR441236 administered at 1, 3, 10, and 30 mg/kg intravenously (IV) and at 1 mg/kg subcutaneously (SC) to healthy adults
2. To evaluate the plasma concentrations and pharmacokinetics (PK) of SAR441236 administered at 1, 3, 10, and 30 mg/kg IV and at 1 mg/kg SC to healthy adults
3. To evaluate the serum neutralizing activity of SAR441236 administered at 1, 3, 10, and 30 mg/kg IV and at 1 mg/kg SC to healthy adults