Healthy ParticipantsPhase 1NCT06084598
A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986446 in Healthy Participants and Healthy Participants of Japanese Ethnicity
A Phase 1 study testing BMS-986446 in people with Healthy Participants, 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-986446 in healthy participants including healthy participants of Japanese ethnicity. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- BMS-986446
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2023to 8 Mar 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant must be of Japanese ethnicity (both biological parents are ethnically Japanese) for Part 1 and Part 2, Panel 2. No limitations on ethnicity apply to Part 2, Panel 1
- Participant is healthy, without any significant abnormalities in medical history, physical examination, ECGs, or clinical laboratory assessments determinations, as assessed by the investigator
- Body mass index (BMI) of at least 18 kg/m^2 but no more than 32 kg/m^2 at screening
- Body weight between 45 kg and 110 kg
Who cannot join
- Any clinically significant deviation from normal, as judged by the investigator
- Any major surgery within 90 days of study drug administration
- Participation in another interventional clinical trial concurrent with this study
- Note: 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, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravenously Administered BMS-986446 in Healthy Participants Including Healthy Participants of Japanese Ethnicity
The purpose of this study is to evaluate the safety, tolerability and drug levels of BMS-986446 in healthy participants including healthy participants of Japanese ethnicity.
- Conditions
- Healthy Participants
- Being tested
- BMS-986446, Placebo
- Keywords
- Pharmacokinetics, Healthy Participants, Healthy Japanese Participants, BMS-986446, PRX005
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986446Drug
Specified dose on specified days
PlaceboOther
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| BMS-986446 | Experimental | Not described Receives: Drug: BMS-986446 |
| Placebo | Experimental | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
Measured: Up to Day 85
Number of participants with vital sign abnormalities
Measured: Up to Day 85
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to Day 85
Number of participants with physical examination abnormalities
Measured: Up to Day 85
Number of participants with body weight abnormalities
Measured: Up to Day 85
Number of participants with clinical laboratory abnormalities
Measured: Up to Day 85
Secondary outcomes (7)
Maximum observed plasma concentration (Cmax)
Measured: Up to Day 85
Time of maximum observed plasma concentration (Tmax)
Measured: Up to Day 85
Area under concentration time curve from time 0 to time of last quantifiable concentration [AUC(0-T)]
Measured: Up to Day 85
Number of participants with anti-drug antibody (ADA)
Measured: Up to Day 85
Geometric mean ratios of Cmax
Measured: Up to Day 85
Geometric mean ratios of [AUC(0-T)]
Measured: Up to Day 85
Geometric mean ratios of area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Measured: Up to Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start12 Oct 2023
- Primary completion8 Mar 2024
- Study completion8 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 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
- NCT06084598
- Sponsor's protocol ID
- CN008-0016
- Status last verified
- Mar 2024
- First submitted
- 10 Oct 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravenously Administered BMS-986446 in Healthy Participants Including Healthy Participants of Japanese Ethnicity
- ClinicalTrials.gov ID
- NCT06084598
- Acronym / sponsor ID
- CN008-0016
- Conditions
- Healthy Participants
- Keywords
- Pharmacokinetics, Healthy Participants, Healthy Japanese Participants, BMS-986446, PRX005
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 8 Mar 2024 (actual)
- Study completion
- 8 Mar 2024 (actual)
- First posted
- 16 Oct 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 and drug levels of BMS-986446 in healthy participants including healthy participants of Japanese ethnicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMS-986446 | Experimental | Drug: BMS-986446 |
| Placebo | Experimental | Other: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant must be of Japanese ethnicity (both biological parents are ethnically Japanese) for Part 1 and Part 2, Panel 2. No limitations on ethnicity apply to Part 2, Panel 1
- Participant is healthy, without any significant abnormalities in medical history, physical examination, ECGs, or clinical laboratory assessments determinations, as assessed by the investigator
- Body mass index (BMI) of at least 18 kg/m^2 but no more than 32 kg/m^2 at screening
- Body weight between 45 kg and 110 kg
Key exclusion criteria (4 listed)
- Any clinically significant deviation from normal, as judged by the investigator
- Any major surgery within 90 days of study drug administration
- Participation in another interventional clinical trial concurrent with this study
- Note: 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-986446Specified dose on specified days | Drug | BMS-986446 |
| PlaceboSpecified dose on specified days | Other | Placebo |
Primary outcome
Incidence of adverse events (AEs)
Time frame: Up to Day 85
Number of participants with vital sign abnormalities
Time frame: Up to Day 85
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to Day 85
Number of participants with physical examination abnormalities
Time frame: Up to Day 85
Number of participants with body weight abnormalities
Time frame: Up to Day 85
Number of participants with clinical laboratory abnormalities
Time frame: Up to Day 85
7 secondary outcomes
Maximum observed plasma concentration (Cmax)
Time frame: Up to Day 85
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to Day 85
Area under concentration time curve from time 0 to time of last quantifiable concentration [AUC(0-T)]
Time frame: Up to Day 85
Number of participants with anti-drug antibody (ADA)
Time frame: Up to Day 85
Geometric mean ratios of Cmax
Time frame: Up to Day 85
Geometric mean ratios of [AUC(0-T)]
Time frame: Up to Day 85
Geometric mean ratios of area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Time frame: Up to Day 85
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 15 Mar 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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. 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-986446 in people with Healthy Participants, 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 4 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 15 Mar 2024. 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?
Incidence of adverse events (AEs) (time frame: Up to Day 85). The study lists 6 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 15 Mar 2024.