Pharmacokinetics of SAR441236

Summary

Participation Requirements

Description

This study will evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of SAR441236, a tri-specific broadly neutralizing antibody against HIV. The study includes three arms. In Arm A, three cohorts of antiretroviral-treated, virologically suppressed participants will be randomiz...

This study will evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of SAR441236, a tri-specific broadly neutralizing antibody against HIV. The study includes three arms. In Arm A, three cohorts of antiretroviral-treated, virologically suppressed participants will be randomized to receive a single intravenous (IV) dose of SAR441236 or placebo on Day 0. After Cohort 1, each subsequent cohort will open for enrollment only after an evaluation of safety outcomes for all participants in the previous cohort indicates that it is safe to increase the dose of SAR441236. All participants in Cohorts 1-3 will be followed for 24 weeks. In Arm A, Cohort 4, participants will be randomized to receive an IV infusion of SAR441236 or placebo once every 12 weeks beginning at entry, for a total of 4 infusions. Participants in this cohort will be followed for 36 weeks after their final infusion. Participants in Arm A will continue taking non-study-provided antiretroviral treatment throughout the study. In Arm B, five cohorts of viremic participants will each receive a single IV dose of SAR441236 on Day 0. Each subsequent Arm B cohort will be opened for enrollment only after an evaluation of efficacy data from Day 14 for all participants in the previous cohort. All Arm B participants will be followed for 24 weeks. Participants in Arm B will initiate or re-initiate non-study-provided combination antiretroviral therapy (ART) (selected by their primary HIV clinician) on Day 28. In Arm C, two cohorts of ART-treated, virologically suppressed participants each will be randomized to receive a single subcutaneous (SC) dose of SAR441236 or placebo on Day 0. Cohort 11 will open for enrollment only after an evaluation of safety outcomes from Day 14 for all participants in Cohort 10 and the cumulative data from all the previous cohorts indicates it is safe to dose escalate. All Arm C participants will be followed for 24 weeks. Participants in Arm C will continue taking non-study-provided ART throughout the study.

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