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Recruiting NCT07604558

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

Phase I Interventional Healthy Volunteer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bretisilocin.
Who it may be relevant to
Registry conditions: Healthy Volunteer. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

  • Drug Bretisilocin
    Intramuscular Injection

Primary outcome measures

  • Number of Participants Experiencing Adverse Events [Time frame: Up to approximately 32 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • CenExel Collaborative Neuroscience Research /ID# 281612 — Los Alamitos

Identifiers

NCT: NCT07604558 · M26-308

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗