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

Recruiting now · Phase 1

Conditions studied: Healthy Volunteer

In brief

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.

Key facts

Study ID

NCT07604558

Run by

AbbVie

People needed

26

Starts

2026-05-26

Expected to finish

2026-09-01

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• CenExel Collaborative Neuroscience Research /ID# 281612 — Los Alamitos, California, United States (enrolling)

Full record on ClinicalTrials.gov

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