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

Purpose

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.

Condition

  • Healthy Volunteer

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group 1-Bretisilocin-Japanese 		Participants will receive bretisilocin intramuscular (IM) injection on day 1.
  • Drug: Bretisilocin
    Intramuscular Injection
Experimental
Group 1-Bretisilocin-Han Chinese 		Participants will receive bretisilocin intramuscular (IM) injection on day 1.
  • Drug: Bretisilocin
    Intramuscular Injection
Experimental
Group 1-Bretisilocin-Non-Asian 		Participants will receive bretisilocin intramuscular (IM) injection on day 1.
  • Drug: Bretisilocin
    Intramuscular Injection

Recruiting Locations

CenExel Collaborative Neuroscience Research /ID# 281612
Los Alamitos, California 90720

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com