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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAbbVie

About this trial

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 criteria

Qualifiers

Group 1: Healthy adult Japanese male or female;

Group 2: Healthy adult Han Chinese male or female

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Bretisilocin

Treatment groups

26 Participants
are divided into 3 treatment groups

Locations

1
CenExel Collaborative Neuroscience Research /ID# 28161290720, Los AlamitosCalifornia, United States

Sponsors and collaborators

AbbVie

Lead sponsor