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

NCT07604558 | Not Yet Recruiting Phase 1

• 1 other identifier: M26-308
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer; Bretisilocin; ABBV-2505

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Adverse Events

  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.

  Up to approximately 32 days

Study Arms (3)

Group 1-Bretisilocin-Japanese

EXPERIMENTAL

Participants will receive bretisilocin intramuscular (IM) injection on day 1.

Drug: Bretisilocin

Group 1-Bretisilocin-Han Chinese

EXPERIMENTAL

Participants will receive bretisilocin intramuscular (IM) injection on day 1.

Drug: Bretisilocin

Group 1-Bretisilocin-Non-Asian

EXPERIMENTAL

Participants will receive bretisilocin intramuscular (IM) injection on day 1.

Drug: Bretisilocin

Interventions

Bretisilocin DRUG

Intramuscular Injection

Group 1-Bretisilocin-Han Chinese; Group 1-Bretisilocin-Japanese; Group 1-Bretisilocin-Non-Asian

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): May 26, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share