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NCT07604558PHASE1RecruitingAccepts Healthy Volunteers

A Study to Assess the Adverse Events and How Bretisilocin Intramuscular Injection Moves Through the Body of Healthy Adult Participants

AbbVie

Start Date

5/26/2026

Completion Date

9/1/2026

Summary

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

Age Range: 18 years to 65 years

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 first-generation Han Chinese of full Chinese parentage residing outside of China for less than 5 years. * 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. Exclusion Criteria: * 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.

Interventions

DRUG

Bretisilocin

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Conditions

Healthy Volunteer

Locations

CenExel Collaborative Neuroscience Research /ID# 281612

Los Alamitos, California 90720

United States