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Clinical Trials in the USA / NCT07604558
Active, not recruiting Phase 1

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

NCT07604558 · tracked via the Priya Life Science USA tracker
Sponsor
AbbVie
Phase
Phase 1
Started
2026-05-26
Last updated
2026-08-31

Condition(s) studied

Healthy Volunteer

Investigational drug(s) / intervention(s)

Bretisilocin

Bretisilocin: Intramuscular Injection

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
CenExel Collaborative Neuroscience Research /ID# 281612 Los Alamitos California

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07604558 on ClinicalTrials.gov ↗ ← All trials in the USA