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New drug bretisilocin tested in healthy volunteers for first time

NCT ID NCT07604558

Knowledge-focused Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 2 times

Summary

This early-stage trial is testing a single dose of bretisilocin in 26 healthy adults from Japanese, Han Chinese, and Non-Asian backgrounds. Researchers are checking for side effects and how the drug moves through the body. The goal is to gather basic safety information before testing in people with a disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bretisilocin
What this could lead to
If successful, this study could provide early safety data to support future trials of bretisilocin for potential therapeutic uses.
What could go wrong
This is a very early Phase 1 trial with only 26 healthy volunteers, so results may not predict effects in patients. The drug could cause unexpected side effects or fail to show promise in later studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

26 people

The number who actually took part.

Started

May 2026

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy volunteer

Contacts and locations

Locations

  • CenExel Collaborative Neuroscience Research /ID# 281612

    Los Alamitos, California, 90720, United States

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