Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bretisilocin · 1 trial · 1 indication
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...
Bretisilocin is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a single active trial assessing its safety and how it moves through the body. It is not approved for any condition and remains in early-stage clinical testing.
Bretisilocin is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting a Phase 1 study of this investigational small molecule in healthy adult participants in the United States.
Bretisilocin is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is active but not recruiting participants, and it is designed to evaluate the drug's adverse events and pharmacokinetics in healthy adults.
Bretisilocin is being evaluated in one active Phase 1 clinical trial, identified as NCT07604558. This study assesses adverse events and how an intramuscular injection of Bretisilocin moves through the body of healthy adult participants. The trial is enrolling 26 participants in the United States and is currently active but not recruiting.
In the ongoing Phase 1 clinical trial NCT07604558, Bretisilocin is administered as an intramuscular injection. The study is designed to evaluate the adverse events and the movement of the drug through the body of healthy adult participants aged 18 years and older.