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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05366764 | First-in-human Study of SAR443765 in Healthy Participants and in Asthmatic Participants | PHASE1 | COMPLETED | 36 | — | — | Jun 8, 2022 | Feb 24, 2023 | Sep 10, 2025 | 2 | Germany, United Kingdom |
Incidence of adverse events (AEs) and treatment-emergent adverse events (TEAEs)
| Arm | Type | Description |
|---|---|---|
| SAR443765 | EXPERIMENTAL | Single dose administration of SAR443765 |
| Placebo | PLACEBO_COMPARATOR | Placebo to match SAR443765 |
| Name | Type | Description |
|---|---|---|
| SAR443765 | DRUG | solution for injection |
| Placebo | DRUG | solution for injection |
| Salbutamol or levosalbutamol | DRUG | metered dose inhaler |
Inclusion Criteria: * Diagnosis of asthma for at least 12 months and confirmed at screening based on the Global Initiative for Asthma (GINA) 2020 Guidelines * Controlled asthma defined as no more than 1 canister of rescue inhaler per month over the last 3 months prior to baseline * Elevated FeNO le...