Healthy VolunteersPhase 1NCT07887763
A Phase 1 Study to Evaluate Safety, Tolerability, and Drug Levels of BMS-986485 in Healthy Adult Participants
A Phase 1 study testing BMS-986485 in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of the administration of a single ascending doses of BMS-986485 in healthy adult 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-986485
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2026to 8 Jun 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 have body mass index (BMI) range of 18 to 33 kg/m2.
Who cannot join
- Participants must not have any significant medical condition (including but, not limited to, neurological, GI, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders).
- Participants mut not have any major surgery or planned surgery (except GI surgery) within 12 weeks of study intervention administration.
- Participants mut not have history of neurological condition (including stroke, traumatic brain injury, intracranial or intraspinal bleeding, or major neurological disorders).
- Other protocol defined inclusion/exclusion criteria apply.
Trial locations and contacts
1 site in 1 country. 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
United States1 site
Local Institution - 0001
Salt Lake City, Utah, 84124-1365
Site 0001
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, First-in-Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of Orally Administered BMS-986485 in Healthy Adult Participants (Part A), and a Conditional Open-label Study to Evaluate the Relative Bioavailability of Alternate Formulations of BMS-986485 in Healthy Adult Participants (Part B)
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of the administration of a single ascending doses of BMS-986485 in healthy adult participants.
- Conditions
- Healthy Volunteers
- Being tested
- BMS-986485, BMS-986485 matching placebo
- Keywords
- Healthy, BMS-986485, Single ascending dose, Phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986485Drug
Specified dose on specified days
BMS-986485 matching placeboOther
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part A: SAD | Experimental | Not described Receives: Drug: BMS-986485; Other: BMS-986485 matching placebo |
| Part B: Conditional rBA | Experimental | Not described Receives: Drug: BMS-986485 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Measured: Up to approximately Day 29
Number of participants with Serious Adverse Events (SAEs)
Measured: Up to approximately Day 29
Number of participants with Vital Signs abnormalities
Measured: Up to approximately Day 29
Number of participants with Physical Examination abnormalities
Measured: Up to approximately Day 29
Number of Participants with 12-Lead Electrocardiogram (ECG) abnormalities
Measured: Up to approximately Day 9
Number of Participants with Holter ECG abnormalities
Part A
Measured: Up to Day 2
Number of participants with Clinical Laboratory abnormalities
Measured: Up to approximately Day 29
Number of participants with suicidal ideation and behavior assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
Measured: Up to Day 9
Time of maximum observed blood concentration (Tmax)
Part B
Measured: Up to Day 6
Maximum observed blood concentration (Cmax)
Part B
Measured: Up to Day 6
Apparent total body clearance (CL/F)
Part B
Measured: Up to Day 6
Apparent volume of distribution during the terminal phase (Vz/F)
Part B
Measured: Up to Day 6
Apparent Terminal Phase Half-life (T-HALF)
Part B
Measured: Up to Day 6
Geometric mean ratios (GMRs) of Cmax
Part B
Measured: Up to Day 6
GMRs of AUC(0-T)
Part B
Measured: Up to Day 6
GMRs of AUC(INF)
Part B
Measured: Up to Day 6
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Part B
Measured: Up to Day 6
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Part B
Measured: Up to Day 6
Secondary outcomes (7)
Time of maximum observed blood concentration (Tmax)
Measured: Up to Day 7
Maximum observed blood concentration (Cmax)
Measured: Up to Day 7
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Measured: Up to Day 7
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Measured: Up to Day 7
Apparent total body clearance (CL/F)
Measured: Up to Day 7
Apparent volume of distribution during the terminal phase (Vz/F)
Measured: Up to Day 7
Apparent Terminal Phase Half-life (T-HALF)
Measured: Up to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start3 Nov 2026 (estimated)
- Primary completion8 Jun 2027 (estimated)
- Study completion8 Jun 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 Bristol-Myers SquibbThe 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- 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
- NCT07887763
- Sponsor's protocol ID
- CN011-0025
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, First-in-Human Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of Orally Administered BMS-986485 in Healthy Adult Participants (Part A), and a Conditional Open-label Study to Evaluate the Relative Bioavailability of Alternate Formulations of BMS-986485 in Healthy Adult Participants (Part B)
- ClinicalTrials.gov ID
- NCT07887763
- Acronym / sponsor ID
- CN011-0025
- Conditions
- Healthy Volunteers
- Keywords
- Healthy, BMS-986485, Single ascending dose, Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2026 (estimated)
- Primary completion
- 8 Jun 2027 (estimated)
- Study completion
- 8 Jun 2027 (estimated)
- First posted
- 21 Oct 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 this study is to evaluate the safety, tolerability, and pharmacokinetics of the administration of a single ascending doses of BMS-986485 in healthy adult participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: SAD | Experimental | Drug: BMS-986485, Other: BMS-986485 matching placebo |
| Part B: Conditional rBA | Experimental | Drug: BMS-986485 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants must have body mass index (BMI) range of 18 to 33 kg/m2.
Key exclusion criteria (4 listed)
- Participants must not have any significant medical condition (including but, not limited to, neurological, GI, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders).
- Participants mut not have any major surgery or planned surgery (except GI surgery) within 12 weeks of study intervention administration.
- Participants mut not have history of neurological condition (including stroke, traumatic brain injury, intracranial or intraspinal bleeding, or major neurological disorders).
- 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-986485Specified dose on specified days | Drug | Part A: SAD, Part B: Conditional rBA |
| BMS-986485 matching placeboSpecified dose on specified days | Other | Part A: SAD |
Primary outcome
Number of participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to approximately Day 29
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to approximately Day 29
Number of participants with Vital Signs abnormalities
Time frame: Up to approximately Day 29
Number of participants with Physical Examination abnormalities
Time frame: Up to approximately Day 29
Number of Participants with 12-Lead Electrocardiogram (ECG) abnormalities
Time frame: Up to approximately Day 9
Number of Participants with Holter ECG abnormalities
Time frame: Up to Day 2
Part A
Number of participants with Clinical Laboratory abnormalities
Time frame: Up to approximately Day 29
Number of participants with suicidal ideation and behavior assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to Day 9
Time of maximum observed blood concentration (Tmax)
Time frame: Up to Day 6
Part B
Maximum observed blood concentration (Cmax)
Time frame: Up to Day 6
Part B
Apparent total body clearance (CL/F)
Time frame: Up to Day 6
Part B
Apparent volume of distribution during the terminal phase (Vz/F)
Time frame: Up to Day 6
Part B
Apparent Terminal Phase Half-life (T-HALF)
Time frame: Up to Day 6
Part B
Geometric mean ratios (GMRs) of Cmax
Time frame: Up to Day 6
Part B
GMRs of AUC(0-T)
Time frame: Up to Day 6
Part B
GMRs of AUC(INF)
Time frame: Up to Day 6
Part B
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to Day 6
Part B
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to Day 6
Part B
7 secondary outcomes
Time of maximum observed blood concentration (Tmax)
Time frame: Up to Day 7
Maximum observed blood concentration (Cmax)
Time frame: Up to Day 7
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to Day 7
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to Day 7
Apparent total body clearance (CL/F)
Time frame: Up to Day 7
Apparent volume of distribution during the terminal phase (Vz/F)
Time frame: Up to Day 7
Apparent Terminal Phase Half-life (T-HALF)
Time frame: Up to Day 7
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 21 Oct 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
Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
RecruitingObservational study
Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)
Immunosuppression, Periodontal Disease
RecruitingObservational study
Adaptive Optics Retinal Imaging
Eye Diseases, Healthy Volunteers
RecruitingObservational study
Characterization of Diseases With Salivary Gland Involvement
Healthy Volunteer, Sjogren's Syndrome
RecruitingObservational study
Genetic and Epigenetic Signatures of Translational Aging Laboratory Testing (GESTALT)
Healthy Volunteers, Non-Healthy/Non-Frail
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986485 in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United States.
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 1 inclusion and 4 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 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Number of participants with Treatment Emergent Adverse Events (TEAEs) (time frame: Up to approximately Day 29). The study lists 18 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 21 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.