Healthy VolunteersPhase 1NCT07852962
Study to Assess Drug Levels, Immune Response, Safety and Tolerability of BMS-986446 in Healthy Chinese Participants.
A Phase 1 study testing BMS-986446 in people with Healthy Volunteers, run by Bristol-Myers Squibb.
Trial summary
The purpose of this study is to assess the drug levels, immune response, safety and tolerability of BMS-986446 in healthy Chinese participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BMS-986446
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2027to 18 Jul 2027
- Phase
- Phase 1
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
- Participants must be of Chinese ethnicity (both biological parents are ethnically Chinese).
- Participants must be Healthy adult male and female (as assigned at birth and non-pregnant and non-nursing).
- Participants must have BMI of 18.0 to 28.0 kg/m2.
Who cannot join
- Participants must not have general history of any clinically significant gastrointestinal, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, endocrinological, immune-mediated, or hematological disorder; allergic disease; metabolic disorder; cancer; or cirrhosis.
- 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-blind, Randomized, Placebo-controlled, Single-dose Study to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Tolerability of BMS-986446 Following Intravenous Administration in Healthy Chinese Participants
The purpose of this study is to assess the drug levels, immune response, safety and tolerability of BMS-986446 in healthy Chinese participants.
- Conditions
- Healthy Volunteers
- Being tested
- BMS-986446, Placebo
- Keywords
- Pharmacokinetics, PK, BMS-986446, Healthy Chinese Participants, IV administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986446Drug
Also called PRX005, Moponetug
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.
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
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
Total body clearance in intravenous infusion (CLT)
Measured: Up to Day 85
Volume of distribution of terminal phase in intravenous administration (Vz)
Measured: Up to Day 85
Apparent terminal serum half-life [T-HALF]
Measured: Up to Day 85
Secondary outcomes (8)
Number of participants with anti-drug antibody (ADA) formation
Measured: Up to Day 85
Number of participants with adverse events (AEs)
Measured: Up to approximately 85 days
Number of participants with vital sign abnormalities
Measured: Up to approximately 85 days
Number of participants with 12-lead electrocardiogram (12-lead-ECG) abnormalities
Measured: Up to approximately 85 days
Number of participants with physical examination abnormalities
Measured: Up to approximately 85 days
Number of participants with body weight abnormalities
Measured: Up to approximately 85 days
Number of participants with clinical laboratory abnormalities
Measured: Up to approximately 85 days
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 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start10 Feb 2027 (estimated)
- Primary completion18 Jul 2027 (estimated)
- Study completion18 Jul 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 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
- NCT07852962
- Sponsor's protocol ID
- CN008-0030
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 1 Oct 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