About this trial
This study will assess the adverse events, tolerability, and how bretisilocin intramuscular (IM) Injection moves through the body of healthy adult Japanese, Han Chinese, and Non-Asian volunteers participants.
Eligibility criteria
Qualifiers
Group 1: Healthy adult Japanese male or female;
Group 2: Healthy adult Han Chinese male or female
Group 3: Healthy adult male or female volunteers of African, European, or Latin American descent.
A condition of general good health, based upon the results of a medical history, physical and neurological examination, vital signs, laboratory profile and 12-lead ECG.
Disqualifiers
Current diagnosis or history of any clinically significant mental health disorder, cardiovascular disorder, metabolic disorder, or other disorder requiring pharmacologic or other medical treatment. (Previous psychological support without a diagnosed history of a mental health disorder would not be considered exclusionary.)
Clinically significant personal or familial history (first degree relative) of epilepsy, seizures, convulsions, or other seizure disorder (excluding febrile seizures as a child), previous head trauma or other risk factor for seizure (e.g., electrolyte disturbances, or structural neurological disorders).
Any use of psychoactive substances (including ketamine, esketamine, MDMA, cannabinoids, or nitrous oxide) during the 6 weeks prior to confinement.
Trial design
Treatments tested in this trial
- Bretisilocin
Treatment groups
Locations
1Sponsors and collaborators
AbbVie
Lead sponsor