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Not yet recruitingNCT07887763Updated Oct 21, 2026

A Phase 1 Study to Evaluate Safety, Tolerability, and Drug Levels of BMS-986485 in Healthy Adult Participants

A Phase 1 interventional study of BMS-986485 and BMS-986485 matching placebo in Healthy Volunteers, sponsored by Bristol-Myers Squibb. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment

Updated Oct 21, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Healthy
  • BMS-986485
  • Single ascending dose
  • Phase 1
03

In context

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,562 studies on the registry; 118 are open to participants now.

Of its 435 completed or terminated interventional studies of FDA-regulated products, 227 (52%) have results posted.

Browse Bristol-Myers Squibb studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants must have body mass index (BMI) range of 18 to 33 kg/m2.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Part A: SAD

    Drug: BMS-986485 · Other: BMS-986485 matching placebo

  • Experimental
    Part B: Conditional rBA

    Drug: BMS-986485

Interventions

  • DrugBMS-986485

    Specified dose on specified days

  • OtherBMS-986485 matching placebo

    Specified dose on specified days

06

What researchers measure

Primary outcomes

  1. Number of participants with Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to approximately Day 29

  2. Number of participants with Serious Adverse Events (SAEs)

    Time frame: Up to approximately Day 29

  3. Number of participants with Vital Signs abnormalities

    Time frame: Up to approximately Day 29

  4. Number of participants with Physical Examination abnormalities

    Time frame: Up to approximately Day 29

  5. Number of Participants with 12-Lead Electrocardiogram (ECG) abnormalities

    Time frame: Up to approximately Day 9

  6. Number of Participants with Holter ECG abnormalities

    Part A

    Time frame: Up to Day 2

  7. Number of participants with Clinical Laboratory abnormalities

    Time frame: Up to approximately Day 29

  8. Number of participants with suicidal ideation and behavior assessed by Columbia Suicide Severity Rating Scale (C-SSRS)

    Time frame: Up to Day 9

  9. Time of maximum observed blood concentration (Tmax)

    Part B

    Time frame: Up to Day 6

  10. Maximum observed blood concentration (Cmax)

    Part B

    Time frame: Up to Day 6

  11. Apparent total body clearance (CL/F)

    Part B

    Time frame: Up to Day 6

  12. Apparent volume of distribution during the terminal phase (Vz/F)

    Part B

    Time frame: Up to Day 6

  13. Apparent Terminal Phase Half-life (T-HALF)

    Part B

    Time frame: Up to Day 6

  14. Geometric mean ratios (GMRs) of Cmax

    Part B

    Time frame: Up to Day 6

  15. GMRs of AUC(0-T)

    Part B

    Time frame: Up to Day 6

  16. GMRs of AUC(INF)

    Part B

    Time frame: Up to Day 6

  17. Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

    Part B

    Time frame: Up to Day 6

  18. Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

    Part B

    Time frame: Up to Day 6

Secondary outcomes

  1. Time of maximum observed blood concentration (Tmax)

    Time frame: Up to Day 7

  2. Maximum observed blood concentration (Cmax)

    Time frame: Up to Day 7

  3. Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

    Time frame: Up to Day 7

  4. Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

    Time frame: Up to Day 7

  5. Apparent total body clearance (CL/F)

    Time frame: Up to Day 7

  6. Apparent volume of distribution during the terminal phase (Vz/F)

    Time frame: Up to Day 7

  7. Apparent Terminal Phase Half-life (T-HALF)

    Time frame: Up to Day 7

07

Study locations

1 site
  • Local Institution - 0001
    Salt Lake City, Utah 84124-1365, United States
    • Site 0001 · Contact
08

References and documents

Individual participant data

Plan to share: 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

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: See Plan Description

Access criteria: See Plan Description

Data sharing details ↗ · www.bms.com

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Jun 2027, 7 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 14, 2026
First posted
Oct 21, 2026
StartEst.
Nov 3, 2026
Primary completionEst.
Jun 8, 2027
CompletionEst.
Jun 8, 2027
Last update
Oct 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07887763
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Oct 21, 2026
Start date
Nov 3, 2026 (estimated)
Primary completion
Jun 8, 2027 (estimated)
Completion
Jun 8, 2027 (estimated)
Last update
Oct 21, 2026

Study contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Contact
Clinical.Trials@bms.com
855-907-3286
First line of the email MUST contain NCT # and Site #.
Contact
Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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