Healthy VolunteersPhase 1NCT07283263
A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986521 in Healthy Participants.
A Phase 1 study testing BMS-985521 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 drug levels of BMS-986521 following single and multiple ascending doses of BMS-986521 in healthy adult participants, and to evaluate potential food effects on BMS-986521 exposure. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BMS-985521
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2025to 17 Nov 2026
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be healthy males and females (assigned at birth) who are not of childbearing potential, with no clinically significant abnormalities in medical history, physical exam, ECG, or lab tests.
- Participants must have a body mass index (BMI) between 18 and 32 kg/m² (inclusive) and body weight of at least 50 kg.
- For Part B/Cohort 11 only: participants with stable cardiovascular conditions may be included if deemed suitable by the investigator.
Who cannot join
- Participants must not have any significant medical condition or history (renal, hepatic, hematologic, GI, endocrine, pulmonary, neurologic, or immunologic) that may affect drug absorption, distribution, metabolism, or excretion (ADME), or pose a risk to the participant.
- Participants must not have a history of rhabdomyolysis, cancer (except certain cured skin or cervical cancers), hematologic malignancy, or myelodysplastic syndrome.
- Participants must not have recent or current significant GI disease, major surgery, or medical interventions affecting ADME (except appendectomy or cholecystectomy).
- Participants must not have had a blood transfusion within 4 weeks or have an inability to tolerate oral medication or venous access.
- 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 the NCT# and Site #. contact
United States1 site, 1 recruiting
- Recruiting
CenExel ACT (Formerly Anaheim Clinical Trials; LLC)
Anaheim, California, 92801
Peter Winkle, Site 0001, 949-295-7809
About this study
Official title: A Phase 1, Randomized, Placebo-Controlled, Double-Blind, First-in-Human Study Evaluating Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Orally Administered BMS-986521 in Healthy Adult Participants
The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986521 following single and multiple ascending doses of BMS-986521 in healthy adult participants, and to evaluate potential food effects on BMS-986521 exposure.
- Conditions
- Healthy Volunteers
- Being tested
- BMS-985521, Placebo
- Keywords
- Healthy Volunteers, Pharmacokinetics, BMS-986521, Placebo, Drug-food Interaction, Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), Elderly, Relative Bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-985521Drug
Specified dose on specified days.
PlaceboOther
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part A Cohort 1 | Experimental | Not described Receives: Drug: BMS-985521; Other: Placebo |
| Part A Cohort 2 | Experimental | Not described Receives: Drug: BMS-985521; Other: Placebo |
| Part A Cohort 3 | Experimental | Not described Receives: Drug: BMS-985521; Other: Placebo |
| Part A Cohort 4 | Experimental | Not described Receives: Drug: BMS-985521; Other: Placebo |
| Part A Cohort 5 | Experimental | Not described Receives: Drug: BMS-985521; Other: Placebo |
| Part A Cohort 6 | Experimental | Not described Receives: Drug: BMS-985521; Other: Placebo |
| Part B Cohort 7 | Experimental | Not described Receives: Drug: BMS-985521; Other: Placebo |
| Part B Cohort 8 | Experimental | Not described Receives: Drug: BMS-985521; Other: Placebo |
| Part B Cohort 9 | Experimental | Not described Receives: Drug: BMS-985521; Other: Placebo |
| Part B Cohort 10 | Experimental | Not described Receives: Drug: BMS-985521; Other: Placebo |
| Part B Cohort 11 | Experimental | Not described Receives: Drug: BMS-985521; Other: Placebo |
| Part C | Experimental | Not described Receives: Drug: BMS-985521 |
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 (AEs)
Measured: Up to approximately Day 40
Number of participants with treatment-emergent serious adverse events (SAEs)
Measured: Up to approximately Day 40
Number of participants with Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Up to approximately Day 14
Secondary outcomes (17)
Maximum Concentration (Cmax) of BMS-986521 in Plasma
Measured: Up to approximately Day 14
Time to Cmax (Tmax) of BMS-986521 in Plasma
Measured: Up to approximately Day 14
Area Under the Concentration-Time Curve from Time Zero to the Last Measured Time Point (AUC(0-T)) of BMS-986521 in Plasma
Measured: Up to approximately Day 14
Area Under the Concentration-Time Curve from Time Zero to 24 Hours (AUC(0-24)) of BMS-986521 in Plasma
Measured: Up to approximately Day 14
Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC(INF)) of BMS-986521 in Plasma
Measured: Up to approximately Day 14
Concentration Over a Dosing Interval (tau) (AUC(TAU)) of BMS-986521 in Plasma
Measured: Up to approximately Day 14
Elimination Half-Life (T-HALF) of BMS-986521 in Plasma
Measured: Up to approximately Day 14
Apparent Clearance of BMS-986521 from Plasma after Dosing (CLT/F)
Measured: Up to approximately Day 14
Apparent Volume of Distribution in Plasma after Dosing (Vz/F) of BMS-986521
Measured: Up to approximately Day 14
Accumulation Index Based on Maximum Concentration (Cmax) in Plasma after Multiple Dosing (AI_Cmax) of BMS-986521
Measured: Up to approximately Day 14
Accumulation Index Based on Area Under the Curve (AUC) in Plasma After Multiple Dosing (AI_AUC) of BMS-986521
Measured: Up to approximately Day 14
Geometric Mean Cmax BMS-986521 under fed and fasted conditions
Cohort 3
Measured: Up to approximately Day 11
Geometric Mean AUC(0-T) BMS-986521 under fed and fasted conditions
Cohort 3
Measured: Up to approximately Day 11
Geometric Mean AUC(INF) BMS-986521 under fed and fasted conditions
Cohort 3
Measured: Up to approximately Day 11
Geometric mean ratios of Cmax for BMS-986521 oral tablet vs solution
Part C
Measured: Up to approximately Day 11
Geometric mean ratios of AUC(0-T) for BMS-986521 oral tablet vs solution
Part C
Measured: Up to approximately Day 11
Geometric mean ratios of AUC(INF) for BMS-986521 oral tablet vs solution
Part C
Measured: Up to approximately Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start23 Dec 2025
- Primary completion17 Nov 2026 (estimated)
- Study completion17 Nov 2026 (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
- 106 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
- NCT07283263
- Sponsor's protocol ID
- CN014-0001
- Status last verified
- Jan 2026
- First submitted
- 2 Dec 2025
- Last updated
- 7 Jan 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/disclosurecommitment.html
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-Controlled, Double-Blind, First-in-Human Study Evaluating Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Orally Administered BMS-986521 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07283263
- Acronym / sponsor ID
- CN014-0001
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers, Pharmacokinetics, BMS-986521, Placebo, Drug-food Interaction, Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), Elderly
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 23 Dec 2025 (actual)
- Primary completion
- 17 Nov 2026 (estimated)
- Study completion
- 17 Nov 2026 (estimated)
- First posted
- 15 Dec 2025 (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 drug levels of BMS-986521 following single and multiple ascending doses of BMS-986521 in healthy adult participants, and to evaluate potential food effects on BMS-986521 exposure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Part A Cohort 1 | Experimental | Drug: BMS-985521, Other: Placebo |
| Part A Cohort 2 | Experimental | Drug: BMS-985521, Other: Placebo |
| Part A Cohort 3 | Experimental | Drug: BMS-985521, Other: Placebo |
| Part A Cohort 4 | Experimental | Drug: BMS-985521, Other: Placebo |
| Part A Cohort 5 | Experimental | Drug: BMS-985521, Other: Placebo |
| Part A Cohort 6 | Experimental | Drug: BMS-985521, Other: Placebo |
| Part B Cohort 7 | Experimental | Drug: BMS-985521, Other: Placebo |
| Part B Cohort 8 | Experimental | Drug: BMS-985521, Other: Placebo |
| Part B Cohort 9 | Experimental | Drug: BMS-985521, Other: Placebo |
| Part B Cohort 10 | Experimental | Drug: BMS-985521, Other: Placebo |
| Part B Cohort 11 | Experimental | Drug: BMS-985521, Other: Placebo |
| Part C | Experimental | Drug: BMS-985521 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be healthy males and females (assigned at birth) who are not of childbearing potential, with no clinically significant abnormalities in medical history, physical exam, ECG, or lab tests.
- Participants must have a body mass index (BMI) between 18 and 32 kg/m² (inclusive) and body weight of at least 50 kg.
- For Part B/Cohort 11 only: participants with stable cardiovascular conditions may be included if deemed suitable by the investigator.
Key exclusion criteria (5 listed)
- Participants must not have any significant medical condition or history (renal, hepatic, hematologic, GI, endocrine, pulmonary, neurologic, or immunologic) that may affect drug absorption, distribution, metabolism, or excretion (ADME), or pose a risk to the participant.
- Participants must not have a history of rhabdomyolysis, cancer (except certain cured skin or cervical cancers), hematologic malignancy, or myelodysplastic syndrome.
- Participants must not have recent or current significant GI disease, major surgery, or medical interventions affecting ADME (except appendectomy or cholecystectomy).
- Participants must not have had a blood transfusion within 4 weeks or have an inability to tolerate oral medication or venous access.
- 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-985521Specified dose on specified days. | Drug | Part A Cohort 1, Part A Cohort 2, Part A Cohort 3, Part A Cohort 4, Part A Cohort 5, Part A Cohort 6, Part B Cohort 10, Part B Cohort 11, Part B Cohort 7, Part B Cohort 8, Part B Cohort 9, Part C |
| PlaceboSpecified dose on specified days | Other | Part A Cohort 1, Part A Cohort 2, Part A Cohort 3, Part A Cohort 4, Part A Cohort 5, Part A Cohort 6, Part B Cohort 10, Part B Cohort 11, Part B Cohort 7, Part B Cohort 8, Part B Cohort 9 |
Primary outcome
Number of participants with treatment-emergent adverse events (AEs)
Time frame: Up to approximately Day 40
Number of participants with treatment-emergent serious adverse events (SAEs)
Time frame: Up to approximately Day 40
Number of participants with Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to approximately Day 14
17 secondary outcomes
Maximum Concentration (Cmax) of BMS-986521 in Plasma
Time frame: Up to approximately Day 14
Time to Cmax (Tmax) of BMS-986521 in Plasma
Time frame: Up to approximately Day 14
Area Under the Concentration-Time Curve from Time Zero to the Last Measured Time Point (AUC(0-T)) of BMS-986521 in Plasma
Time frame: Up to approximately Day 14
Area Under the Concentration-Time Curve from Time Zero to 24 Hours (AUC(0-24)) of BMS-986521 in Plasma
Time frame: Up to approximately Day 14
Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC(INF)) of BMS-986521 in Plasma
Time frame: Up to approximately Day 14
Concentration Over a Dosing Interval (tau) (AUC(TAU)) of BMS-986521 in Plasma
Time frame: Up to approximately Day 14
Elimination Half-Life (T-HALF) of BMS-986521 in Plasma
Time frame: Up to approximately Day 14
Apparent Clearance of BMS-986521 from Plasma after Dosing (CLT/F)
Time frame: Up to approximately Day 14
Apparent Volume of Distribution in Plasma after Dosing (Vz/F) of BMS-986521
Time frame: Up to approximately Day 14
Accumulation Index Based on Maximum Concentration (Cmax) in Plasma after Multiple Dosing (AI_Cmax) of BMS-986521
Time frame: Up to approximately Day 14
Accumulation Index Based on Area Under the Curve (AUC) in Plasma After Multiple Dosing (AI_AUC) of BMS-986521
Time frame: Up to approximately Day 14
Geometric Mean Cmax BMS-986521 under fed and fasted conditions
Time frame: Up to approximately Day 11
Geometric Mean AUC(0-T) BMS-986521 under fed and fasted conditions
Time frame: Up to approximately Day 11
Geometric Mean AUC(INF) BMS-986521 under fed and fasted conditions
Time frame: Up to approximately Day 11
Geometric mean ratios of Cmax for BMS-986521 oral tablet vs solution
Time frame: Up to approximately Day 11
Geometric mean ratios of AUC(0-T) for BMS-986521 oral tablet vs solution
Time frame: Up to approximately Day 11
Geometric mean ratios of AUC(INF) for BMS-986521 oral tablet vs solution
Time frame: Up to approximately Day 11
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 7 Jan 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/disclosurecommitment.html
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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 the 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-985521 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 7 Jan 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 (AEs) (time frame: Up to approximately Day 40). 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 7 Jan 2026.