Trials / Completed
CompletedNCT05846009
A First-in-human Single and Repeated Dose Escalation Study of SAR442501 in Healthy Adults Subjects
A Phase I, First-in-human, Two-part, Randomized, Placebo-controlled, Double-blind, Single and Repeated Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Doses of SAR442501 in Healthy Adult Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 76 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The purpose of the first-in-human (FIH) study is to obtain safety, tolerability, and pharmacokinetic information on SAR442501 in a healthy adult volunteer population using an integrated single ascending dose (SAD)-multiple ascending dose (MAD) parallel cohort study design.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SAR442501 | Subcutaneous injection |
| DRUG | Placebo | Subcutaneous injection |
Timeline
- Start date
- 2020-11-18
- Primary completion
- 2022-01-12
- Completion
- 2022-01-12
- First posted
- 2023-05-06
- Last updated
- 2024-08-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05846009. Inclusion in this directory is not an endorsement.