Healthy VolunteersPhase 1NCT07700329
A Study to Evaluate the Blood Levels, Safety, and Tolerability of BMS-986368 in Healthy Chinese Participants
A Phase 1 study testing BMS-986368 in people with Healthy Volunteers, run by Celgene.
Trial summary
The purpose of the study is to evaluate the drug levels, safety and tolerability of BMS-986368 in healthy Chinese participants Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BMS-986368
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2027to 23 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be healthy male or non-pregnant and non-nursing female (as assigned at birth).
- Participants must be of Chinese ethnicity (both biological parents should be ethnically Chinese).
- Participants must have BMI of 18.0 kg/m2 to 28.0 kg/m2, inclusive and body weight of ≥ 50 kg.
Who cannot join
- Participants must not have personal or first-degree family history of clinically significant psychiatric disorder, including, but not limited to, schizophrenia, psychosis, bipolar disorder, major depressive disorder, generalized anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder. Participants with a history of anxiety may be enrolled at the discretion of the investigator.
- Participants must not have an active or prior history of stroke, chronic seizures, or major neurological disorders or has first-degree family relative who was diagnosed with these disorders below the age of 65 years.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
About this study
Official title: A Phase 1, Double-Blinded, Randomized, Placebo-Controlled, Two Parallel Cohort Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986368 in Healthy Chinese Participants
The purpose of the study is to evaluate the drug levels, safety and tolerability of BMS-986368 in healthy Chinese participants
- Conditions
- Healthy Volunteers
- Being tested
- BMS-986368, BMS-986368-matching Placebo
- Keywords
- BMS-986368, CC-97489, Healthy volunteers, Healthy Chinese participants, Pharmacokinetics, Safety, Tolerability, FAAH inhibitor, MAGL inhibitor, Phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986368Drug
Specified dose on specified days
BMS-986368-matching PlaceboOther
Specified dose of specified days
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Not described Receives: Drug: BMS-986368; Other: BMS-986368-matching Placebo |
| Cohort 2 | Experimental | Not described Receives: Drug: BMS-986368; Other: BMS-986368-matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax)
Measured: Up to approximately Day 17
Time of maximum observed concentration (Tmax)
Measured: Up to approximately Day 17
Area under the concentration-time curve (AUC)
Measured: Up to approximately Day 17
Secondary outcomes (7)
Number of participants with adverse events (AEs)
Measured: Up to approximately Day 44
Number of participants with serious adverse events (SAEs)
Measured: Up to approximately Day 44
Number of participants with clinically significant vital sign measurements
Measured: Up to approximately Day 17
Number of participants with clinically significant 12-lead electrocardiogram (ECG) examinations
Measured: Up to approximately Day 17
Number of participants with clinically significant laboratory assessments
Measured: Up to approximately Day 17
Number of participants with treatment emergent suicidal ideation and behavious assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
Measured: Up to approximately Day 17
Number of participants with changes with anxiety as assessed by Beck Anxiety Inventory (BAI)
Measured: Up to approximately Day 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start5 Jan 2027 (estimated)
- Primary completion23 Feb 2027 (estimated)
- Study completion23 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by CelgeneThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07700329
- Sponsor's protocol ID
- IM045-1027
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blinded, Randomized, Placebo-Controlled, Two Parallel Cohort Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986368 in Healthy Chinese Participants
- ClinicalTrials.gov ID
- NCT07700329
- Acronym / sponsor ID
- IM045-1027
- Conditions
- Healthy Volunteers
- Keywords
- BMS-986368, CC-97489, Healthy volunteers, Healthy Chinese participants, Pharmacokinetics, Safety, Tolerability, FAAH inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2027 (estimated)
- Primary completion
- 23 Feb 2027 (estimated)
- Study completion
- 23 Feb 2027 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the drug levels, safety and tolerability of BMS-986368 in healthy Chinese participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: BMS-986368, Other: BMS-986368-matching Placebo |
| Cohort 2 | Experimental | Drug: BMS-986368, Other: BMS-986368-matching Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants must be healthy male or non-pregnant and non-nursing female (as assigned at birth).
- Participants must be of Chinese ethnicity (both biological parents should be ethnically Chinese).
- Participants must have BMI of 18.0 kg/m2 to 28.0 kg/m2, inclusive and body weight of ≥ 50 kg.
Key exclusion criteria (3 listed)
- Participants must not have personal or first-degree family history of clinically significant psychiatric disorder, including, but not limited to, schizophrenia, psychosis, bipolar disorder, major depressive disorder, generalized anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder. Participants with a history of anxiety may be enrolled at the discretion of the investigator.
- Participants must not have an active or prior history of stroke, chronic seizures, or major neurological disorders or has first-degree family relative who was diagnosed with these disorders below the age of 65 years.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986368Specified dose on specified days | Drug | Cohort 1, Cohort 2 |
| BMS-986368-matching PlaceboSpecified dose of specified days | Other | Cohort 1, Cohort 2 |
Primary outcome
Maximum observed concentration (Cmax)
Time frame: Up to approximately Day 17
Time of maximum observed concentration (Tmax)
Time frame: Up to approximately Day 17
Area under the concentration-time curve (AUC)
Time frame: Up to approximately Day 17
7 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Up to approximately Day 44
Number of participants with serious adverse events (SAEs)
Time frame: Up to approximately Day 44
Number of participants with clinically significant vital sign measurements
Time frame: Up to approximately Day 17
Number of participants with clinically significant 12-lead electrocardiogram (ECG) examinations
Time frame: Up to approximately Day 17
Number of participants with clinically significant laboratory assessments
Time frame: Up to approximately Day 17
Number of participants with treatment emergent suicidal ideation and behavious assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to approximately Day 17
Number of participants with changes with anxiety as assessed by Beck Anxiety Inventory (BAI)
Time frame: Up to approximately Day 17
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986368 in people with Healthy Volunteers, run by Celgene.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed concentration (Cmax) (time frame: Up to approximately Day 17). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.