A Bioequivalence Study of Amlitelimab Delivered by 2 Different Devices in Healthy Adult Participants
← catalyst calendarSponsored by Sanofi (industry) · SNY — their whole pipeline →.
Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
212actual
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-08-25 | actual | When the study began enrolling |
| Primary completion | 2026-04-08 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-04-08 | actual | The whole study's end, after follow-up |
| First posted | 2025-08-28 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-20 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Healthy Volunteers
Intervention
- Combination product: SAR445229 — also filed as Amlitelimab
Primary outcomes
what the primary-completion date above is the date OFPK parameter: Cmax
measured From Day 1 up to End of study (approximately 24 weeks)
Pharmacokinetic (PK) profile: AUC last
measured From Day 1 up to End of study (approximately 24 weeks)
Pharmacokinetic (PK) profile: AUC
measured From Day 1 up to End of study (approximately 24 weeks)
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