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Monoclonal Antibodies

BMS-986365 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
Be between 18 and 65 years old
Must not have
Prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, or prolonged QT interval
History of allergy/hypersensitivity to any component (including excipients) of BMS-986365 study interventions or related compounds
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial aims to test how safe and well-tolerated a drug called BMS-986365 is in healthy men. It will also look at how the drug levels are affected by food and compare

Who is the study for?
This trial is for healthy adult men who can participate in a study to assess the safety of a new medication. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and have no conflicting medical conditions.
What is being tested?
The study is testing BMS-986365, possibly a new drug, looking at how safe it is and how the body processes it. It will also compare the effects of taking it with food versus without and its bioavailability compared to Rabeprazole.
What are the potential side effects?
Since this is an early-stage trial for BMS-986365, specific side effects are not listed but may include typical drug trial reactions such as nausea, headaches, or allergic responses.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of serious heart conditions.
Select...
I am not allergic to any part of the BMS-986365 treatment.

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

10Treatment groups
Experimental Treatment
Group I: Part 2: Cohort 5 BMS-986365 Dose 10 Fasted Followed by Rabeprazole + Rabeprazole and BMS-986365Experimental Treatment1 Intervention
Group II: Part 2: Cohort 4 BMS-986365 Dose 9 FedExperimental Treatment1 Intervention
Group III: Part 2: Cohort 4 BMS-986365 Dose 8 FastedExperimental Treatment1 Intervention
Group IV: Part 1: Cohort 8 BMS-986365 Dose 7Experimental Treatment1 Intervention
Group V: Part 1: Cohort 7 BMS-986365 Dose 6Experimental Treatment1 Intervention
Group VI: Part 1: Cohort 6 BMS-986365 Dose 5Experimental Treatment1 Intervention
Group VII: Part 1: Cohort 3 BMS-986365 Dose 4Experimental Treatment1 Intervention
Group VIII: Part 1: Cohort 2 BMS-986365 Dose 3 Formulation 2Experimental Treatment1 Intervention
Group IX: Part 1: Cohort 2 BMS-986365 Dose 2 Formulation 1Experimental Treatment1 Intervention
Group X: Part 1: Cohort 1 BMS-986365 Dose 1Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rabeprazole
2017
Completed Phase 4
~4220

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
130,467 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,559 Previous Clinical Trials
3,383,634 Total Patients Enrolled
~16 spots leftby Nov 2024
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