Study Details

Protocol Status: Withdrawn
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

Key Study Personnel

Katharine Bar, Protocol Chair
David Burns, DAIDS Medical Officer
Jontraye Davis, Protocol Team Member
Bonnie Dye, LOC Clinical Research Manager
Theresa Gamble, LOC Clinical Research Manager
Margarita Gomez, DAIDS Medical Officer
Abraham Johnson, Protocol Team Member
Carissa Karg, HVTN Clinical Trials Manager
Shelly Karuna, HVTN Clinical Trials Manager
Denni Lennon, LC QAQC
David Montefiori, LC Representative
Estelle Piwowar-Manning, LC Representative
Hyman Scott, Protocol Chair
Katie Shin, DAIDS Pharmacist

Study Sites List