Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07146750 | A Bioequivalence Study of Amlitelimab Delivered by 2 Different Devices in Healthy Adult Participants | PHASE1 | COMPLETED | 212 | — | — | Aug 25, 2025 | Apr 8, 2026 | Apr 20, 2026 | 1 | United States |
Maximum serum concentration observed.
Area under the serum concentration versus time curve calculated using the trapezoidal method from time zero to the real time.
Area under the serum concentration versus time curve extrapolated to infinity.
| Arm | Type | Description |
|---|---|---|
| Group 1 | ACTIVE_COMPARATOR | Participants will receive a single dose of subcutaneous amlitelimab (dose A) to the abdomen delivered by prefilled syringe (PFS). |
| Group 2 | EXPERIMENTAL | Participants will receive a single dose subcutaneous amlitelimab (dose A) to the abdomen delivered by prefilled pen (PFP). |
| Group 3 | ACTIVE_COMPARATOR | Participants will receive a single dose of subcutaneous amlitelimab (dose B) to the abdomen delivered by PFS. |
| Group 4 | EXPERIMENTAL | Participants will receive a single dose of subcutaneous amlitelimab (dose B) to the abdomen delivered by PFP. |
| Name | Type | Description |
|---|---|---|
| SAR445229 | COMBINATION_PRODUCT | Single dose |
Inclusion Criteria: * Male and/or female participant, between 18 and 55 years of age, inclusive, at the time of signing the informed consent form (ICF). * Certified as healthy by a comprehensive clinical assessment \[detailed medical history and complete physical examination including neurological ...