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Monoclonal Antibodies

BMS-986368 for Healthy Subjects

Phase 1
Recruiting
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be healthy male or non-pregnant and non-nursing female individuals
Participants must have normal renal function at screening
Must not have
Participants must not have any significant acute or chronic neurological illness (e.g., history of intracranial or intraspinal hemorrhage, CNS lesions, recent bacterial or fungal meningitis, etc.) as determined by the investigator
Participants must not have a personal or first-degree family history of clinically significant psychiatric disorder, including schizophrenia, psychosis, bipolar disorder, panic disorder, generalized anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial aims to test the safety, side effects, and how the body processes a drug called BMS-986368 when taken by mouth in different groups of people, including healthy individuals, elderly people

Who is the study for?
This trial is for healthy adults, including the elderly and individuals of Japanese ethnicity. Specific eligibility criteria are not detailed, but typically participants must be in good health without any significant medical conditions.
What is being tested?
The study is testing BMS-986368, a new medication taken by mouth. It aims to assess how safe it is, how well people can tolerate it, and what happens to drug levels in the body after taking it.
What are the potential side effects?
Since this information isn't provided directly, potential side effects are unknown. However, common side effects in such trials may include nausea, headache, dizziness or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a healthy male or a female not pregnant or nursing.
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My kidney function is normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any serious brain or nerve conditions.
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I do not have, nor does anyone in my immediate family have a history of major psychiatric disorders.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

9Treatment groups
Experimental Treatment
Group I: Cohort 3BExperimental Treatment1 Intervention
Group II: Cohort 3AExperimental Treatment1 Intervention
Group III: Cohort 2DExperimental Treatment1 Intervention
Group IV: Cohort 2CExperimental Treatment1 Intervention
Group V: Cohort 2BExperimental Treatment1 Intervention
Group VI: Cohort 2AExperimental Treatment1 Intervention
Group VII: Cohort 1CExperimental Treatment1 Intervention
Group VIII: Cohort 1BExperimental Treatment1 Intervention
Group IX: Cohort 1AExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BMS-986368
2024
Completed Phase 1
~40

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

CelgeneLead Sponsor
645 Previous Clinical Trials
130,485 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,559 Previous Clinical Trials
3,383,652 Total Patients Enrolled
~0 spots leftby Oct 2024
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