Trials / Completed
CompletedNCT05845996
Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Single and Repeated Doses of SAR441344 in Healthy Adult Subjects
A Randomized, Double-blind, Parallel Design, Placebo-controlled Single and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous Doses of SAR441344 in Healthy Adult Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 56 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
Primary Objective is the tolerability and safety of ascending single and repeated intravenous infusion (IV) and/or subcutaneous (SC) administration of SAR441344
Detailed description
The study duration of Part 1 is approximately 22 weeks, including a treatment period of 1 day; The study duration of Part 2 is approximately 26 weeks for each subject, including a treatment period of 29 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SAR441344 | Solution for intravenous/subcutaneous injection |
| DRUG | placebo | Solution for intravenous/subcutaneous injection |
| BIOLOGICAL | Keyhole limpet hemocyanin | Subcutaneous Lyophilized powder for reconstitution |
Timeline
- Start date
- 2018-11-08
- Primary completion
- 2020-04-10
- Completion
- 2020-04-10
- First posted
- 2023-05-06
- Last updated
- 2025-09-16
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05845996. Inclusion in this directory is not an endorsement.