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Monoclonal Antibodies

Part A (SAD) for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy Participants (Part A and Part B)
Healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination (PE), electrocardiograms (ECGs), and clinical laboratory determinations
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 137 days
Awards & highlights

Study Summary

This trial tests a drug (BMS-986325) on healthy people and those with Sjögren's Syndrome to see if it's safe to use and how it affects them.

Eligible Conditions
  • Healthy Subjects
  • Sjögren's Syndrome

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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This study is seeking both healthy volunteers and patients with a medical condition.
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You are in good health and have no major medical problems based on your medical history, physical exam, heart tests, and lab results.
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You must be between the ages of 18 and 50 years old.
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Your body mass index (BMI) is between 18.0 to 30.0 kg/m2 and you weigh at least 50 kg.
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You must have received all recommended doses of the COVID-19 vaccine.
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You have Sjögren's Syndrome and are applying for Part C of the clinical trial.
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You have Sjögren's syndrome without any other immune-related disease or condition as per the 2016 American College of Rheumatology-European League Against Rheumatism criteria.
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You have antibodies related to Sjögren's syndrome.
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You are between 18 and 75 years old.
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Your body weight and height must be within a certain range (BMI between 18 to 35). You must also weigh at least 50 kilograms during screening.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 137 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 137 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Adverse Events (AEs)
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
+16 more
Secondary outcome measures
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
Maximum observed plasma concentration (Cmax)
Time of maximum observed plasma concentration (Tmax)

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Part C (pSS)Experimental Treatment1 Intervention
Primary Sjögren's Syndrome (pSS)
Group II: Part B (MAD)Experimental Treatment1 Intervention
Multiple Ascending Dose (MAD)
Group III: Part A (SAD)Experimental Treatment1 Intervention
Single Ascending Dose (SAD)
Group IV: Part A (SAD) PlaceboPlacebo Group1 Intervention
Group V: Part B (MAD) PlaceboPlacebo Group1 Intervention
Group VI: Part C (pSS) PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BMS-986325
2023
Completed Phase 1
~30

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,632 Previous Clinical Trials
4,126,504 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant enrollment for this research study?

"Affirmative. According to the information found on clinicaltrials.gov, this trial which was initially posted in February 2021 is presently open for enrollment. 136 out of a total number of participants need to be recruited from 1 specific site."

Answered by AI

How would you characterize the risk associated with Part B (MAD) for individuals?

"Our internal assessment gives Part B (MAD) a rating of 1 due to its lack of clinical evidence. This is expected from such an early stage trial, as the safety and efficacy are yet unproven."

Answered by AI

Is the cutoff age for this research project being conducted above thirty years old?

"This medical study is open to adults aged between 18 and 75. Separately, there are 424 trials available for minors below the age of consent and 1353 studies accessible to those beyond retirement-age."

Answered by AI

Is there an open enrollment period for participants at the moment?

"Affirmative. According to clinicaltrials.gov, this investigation has been recruiting patients since February 16th 2021 and its protocols have recently been updated on February 21st 2023. There are 136 vacancies at a single medical centre."

Answered by AI

Could I potentially qualify for this research endeavor?

"This clinical trial is looking to recruit 136 individuals, which must fall between 18 and 75 years old. Furthermore, participants need to meet the following prerequisites: possess a healthy body with no major medical conditions; both males and females are accepted; BMI needs to be in range of 18-30 kg/m2 for part A & B and from 18-35 kg/m2 for Part C; weight should not drop below 50kg at screening; they have been fully vaccinated against SARS-CoV-2 virus if applicable; those participating in Part C require seropositive test results for anti-Sjögren's syndrome"

Answered by AI

Who else is applying?

What state do they live in?
Mississippi
California
What site did they apply to?
Medvin Clinical Research - Metyas
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
BMS-986325 in Healthy Participants and Participants With Primary Sjögren's Syndrome
2021. "BMS-986325 in Healthy Participants and Participants With Primary Sjögren's Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04684654.
~28 spots leftby Apr 2025
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