Healthy VolunteersPhase 1NCT05813717
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986325 in Healthy Japanese Participants
A Phase 1 study testing BMS-986325 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, pharmacokinetics, and pharmacodynamics of BMS-986325 in healthy Japanese participants Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BMS-986325
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2023to 2 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be ethnically Japanese (both biological parents are ethnically Japanese).
- Healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations.
- Body mass index (BMI) between 18 and 30 kg/m2, inclusive, at screening.
Who cannot join
- Any significant acute or chronic medical illness.
- Any major surgery within 4 weeks prior to study drug administration, or any surgery planned during the course of the study.
- Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status (eg, history of splenectomy).
- Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Doses of BMS-986325 in Healthy Japanese Participants
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-986325 in healthy Japanese participants
- Conditions
- Healthy Volunteers
- Being tested
- BMS-986325, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986325Drug
Specified dose on specified days
PlaceboDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Cohort J1 | Experimental | Not described Receives: Drug: BMS-986325; Drug: Placebo |
| Cohort J2 | Experimental | Not described Receives: Drug: BMS-986325; Drug: Placebo |
| Cohort J3 | Experimental | Not described Receives: Drug: BMS-986325; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse events
Measured: Up to day 92
Number of participants with clinical laboratory abnormalities
Measured: Up to day 64
Number of participants with vital sign abnormalities
Measured: Up to day 64
Number of participants with ECG abnormalities
Measured: Up to day 64
Number of participants with physical examination abnormalities
Measured: Up to day 64
Secondary outcomes (7)
Serum concentrations of BMS-986325
Measured: Up to day 64
Maximum observed serum concentration (Cmax)
Measured: Up to day 64
Time of maximum observed serum concentration (Tmax)
Measured: Up to day 64
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Measured: Up to day 64
Pharmacokinetics/pharmacodynamic (receptor occupancy) (PK/PD (RO)) correlation
Receptor occupancy assays are measured by BMS-986325 binding with fluorescently conjugated antibodies on B cells. Receptor occupancy is calculated as a ratio of fluorescence intensity using unchallenged samples over fluorescence intensity using saturated samples.
Measured: Up to day 64
Absolute Bioavailability (F) of BMS-986325
Measured as a percentage
Measured: Up to day 64
Number of Participants With Anti-Drug Antibody Response
Measured: Up to day 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start10 Apr 2023
- Primary completion2 Oct 2023
- Study completion2 Oct 2023
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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
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
- NCT05813717
- Sponsor's protocol ID
- IM039-1001
- Status last verified
- Oct 2023
- First submitted
- 3 Apr 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Doses of BMS-986325 in Healthy Japanese Participants
- ClinicalTrials.gov ID
- NCT05813717
- Acronym / sponsor ID
- IM039-1001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 2 Oct 2023 (actual)
- Study completion
- 2 Oct 2023 (actual)
- First posted
- 14 Apr 2023 (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, pharmacokinetics, and pharmacodynamics of BMS-986325 in healthy Japanese participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort J1 | Experimental | Drug: BMS-986325, Drug: Placebo |
| Cohort J2 | Experimental | Drug: BMS-986325, Drug: Placebo |
| Cohort J3 | Experimental | Drug: BMS-986325, Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants must be ethnically Japanese (both biological parents are ethnically Japanese).
- Healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations.
- Body mass index (BMI) between 18 and 30 kg/m2, inclusive, at screening.
Key exclusion criteria (4 listed)
- Any significant acute or chronic medical illness.
- Any major surgery within 4 weeks prior to study drug administration, or any surgery planned during the course of the study.
- Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status (eg, history of splenectomy).
- 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-986325Specified dose on specified days | Drug | Cohort J1, Cohort J2, Cohort J3 |
| PlaceboSpecified dose on specified days | Drug | Cohort J1, Cohort J2, Cohort J3 |
Primary outcome
Number of participants with Adverse events
Time frame: Up to day 92
Number of participants with clinical laboratory abnormalities
Time frame: Up to day 64
Number of participants with vital sign abnormalities
Time frame: Up to day 64
Number of participants with ECG abnormalities
Time frame: Up to day 64
Number of participants with physical examination abnormalities
Time frame: Up to day 64
7 secondary outcomes
Serum concentrations of BMS-986325
Time frame: Up to day 64
Maximum observed serum concentration (Cmax)
Time frame: Up to day 64
Time of maximum observed serum concentration (Tmax)
Time frame: Up to day 64
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to day 64
Pharmacokinetics/pharmacodynamic (receptor occupancy) (PK/PD (RO)) correlation
Time frame: Up to day 64
Absolute Bioavailability (F) of BMS-986325
Time frame: Up to day 64
Number of Participants With Anti-Drug Antibody Response
Time frame: Up to day 64
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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. This study is not recruiting at the moment.
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-986325 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 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: finished, as of the sponsor's last update on 7 Nov 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse events (time frame: Up to day 92). The study lists 5 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 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.