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NCT Number: NCT07604558

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CenExel Collaborative Neuroscience Research /ID# 281612

Los Alamitos, California, 90720, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bretisilocin

Drug

Intramuscular Injection

Primary outcomes

  1. Number of Participants Experiencing Adverse Events

    Time frame: Up to approximately 32 days

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

An Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Dose of Bretisilocin in Healthy Adult Japanese, Han Chinese, and Non-Asian Volunteers

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 22, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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