Healthy VolunteerPhase 1NCT07604558
A Study to Assess the Adverse Events and How Bretisilocin Intramuscular Injection Moves Through the Body of Healthy Adult Participants
A Phase 1 study testing Bretisilocin in people with Healthy Volunteer, run by AbbVie at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Bretisilocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2026to 3 Sep 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
CenExel Collaborative Neuroscience Research /ID# 281612
Los Alamitos, California, 90720
About this study
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
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
- Being tested
- Bretisilocin
- Keywords
- Healthy Volunteer, Bretisilocin, ABBV-2505
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BretisilocinDrug
Intramuscular Injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1-Bretisilocin-Japanese | Experimental | Participants will receive bretisilocin intramuscular (IM) injection on day 1. Receives: Drug: Bretisilocin |
| Group 1-Bretisilocin-Han Chinese | Experimental | Participants will receive bretisilocin intramuscular (IM) injection on day 1. Receives: Drug: Bretisilocin |
| Group 1-Bretisilocin-Non-Asian | Experimental | Participants will receive bretisilocin intramuscular (IM) injection on day 1. Receives: Drug: Bretisilocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 32 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start26 May 2026
- Primary completion3 Sep 2026
- Study completion3 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604558
- Sponsor's protocol ID
- M26-308
- Status last verified
- Sep 2026
- First submitted
- 18 May 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No