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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07604558 | A Study to Assess the Adverse Events and How Bretisilocin Intramuscular Injection Moves Through the Body of Healthy Adult Participants | PHASE1 | NOT YET_RECRUITING | 26 | — | — | May 26, 2026 | Sep 1, 2026 | May 22, 2026 | - | — |
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| Group 1-Bretisilocin-Japanese | EXPERIMENTAL | Participants will receive bretisilocin intramuscular (IM) injection on day 1. |
| Group 1-Bretisilocin-Han Chinese | EXPERIMENTAL | Participants will receive bretisilocin intramuscular (IM) injection on day 1. |
| Group 1-Bretisilocin-Non-Asian | EXPERIMENTAL | Participants will receive bretisilocin intramuscular (IM) injection on day 1. |
| Name | Type | Description |
|---|---|---|
| Bretisilocin | DRUG | Intramuscular Injection |
Inclusion Criteria: * Group 1: Healthy adult Japanese male or female; • Japanese participants must be first-generation Japanese of full Japanese parentage residing outside of Japan for less than 5 years. * Group 2: Healthy adult Han Chinese male or female • Han Chinese participants must be fi...