drugset / Trial / NCT03705169
Pharmacokinetics and Safety of SAR441236
Phase 1
Terminated
52 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
ModeX Therapeutics, An OPKO Health Company · collabSanofi · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study was to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of SAR441236, a tri-specific broadly neutralizing antibody against the human immunodeficiency virus (HIV).
Timeline
- Start
- 2019-05-20
- Primary completion
- 2022-04-04
- Completion
- 2022-04-04
Outcome
Outcome not reported
Stopped (Enrollment): “The study closed to enrollment and follow-up in May 2023. There had been no enrollment since October 2021, and by 2023, the available study product had reached its expiration date. Enrollment targets in Arm B had not been met.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SAR441236 | Unknown | 0.3 mg/kg | Intravenous |
| Subject | SAR441236 | Unknown | 1 mg/kg | Intravenous |
| Subject | SAR441236 | Unknown | 3 mg/kg | Intravenous |
| Subject | SAR441236 | Unknown | 10 mg/kg | Intravenous |
| Subject | SAR441236 | Unknown | 30 mg/kg | Intravenous |