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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07604558

Enrollment

Registered

2026-05-22

Start date

2026-05-26

Completion date

2026-09-01

Last updated

2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer, Bretisilocin, ABBV-2505

Brief 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.

Interventions

DRUGBretisilocin

Intramuscular Injection

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants Experiencing Adverse Events	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.

Countries

United States

Contacts

STUDY_DIRECTORABBVIE INC.

AbbVie

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026