BMS-986325 in Healthy Participants and Participants With Primary Sjögren's Syndrome
Phase 1
Terminated
- Conditions
- Healthy ParticipantsPrimary Sjögren's Syndrome
- Interventions
- Biological: BMS-986325Other: Placebo for BMS-986325
- Registration Number
- NCT04684654
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate the safety, tolerability, drug levels, and drug effects of BMS-986325 in healthy participants and participants with primary Sjögren's syndrome. The results will guide the future clinical development with BMS-986325.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 118
Inclusion Criteria
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
- Males and Females, ages 18, or local age of majority, to 50 years, inclusive at screening
- Body mass index (BMI):18.0 to 30.0 kg/m2, weight: ≥ 50 kg at screening
- Must be fully vaccinated against SARS-CoV-2
Participants with Sjögren's Syndrome (Part C)
- Sjögren's syndrome in the absence of another immune-mediated disease or rheumatologic condition based on the 2016 American College of Rheumatology-European League Against Rheumatism (EULAR) Classification Criteria for primary Sjögren's syndrome (pSS). Historical diagnosis as pSS documented in medical records, using the 2016 ACR/EULAR criteria, is also acceptable
- Seropositive for anti-Sjögren's syndrome antigen A antibody (anti-SSA). Previous anti-SSA are also acceptable, and results should be documented in the Case Report Form (CRF) as past medical history
- Males and females, ages 18, or local age of majority, to 75 years, inclusive at screening
- Body mass index (BMI): 18.0 to 35.0 kg/m2; weight ≥ 50 kg at screening
- Must be fully vaccinated against SARS-CoV-2 according to local regulations
Exclusion Criteria
Healthy Participants (Part A and Part B) - Any significant acute or chronic medical illness
Healthy Participants (Part A and Part B) and Participants with Primary Sjögren's Syndrome (pSS) (Part C)
- Any major surgery within 4 weeks prior to study drug administration, or any surgery planned during the course of the study
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A (SAD) BMS-986325 Single Ascending Dose (SAD) Part B (MAD) Placebo Placebo for BMS-986325 - Part C (pSS) Placebo Placebo for BMS-986325 - Part A (SAD) Placebo Placebo for BMS-986325 - Part B (MAD) BMS-986325 Multiple Ascending Dose (MAD) Part C (pSS) BMS-986325 Primary Sjögren's Syndrome (pSS)
- Primary Outcome Measures
Name Time Method Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests Up to 137 days Incidence of clinically significant changes in vital signs: Body temperature Up to 137 days Incidence of clinically significant changes in vital signs: Respiratory rate Up to 137 days Incidence of clinically significant changes in vital signs: Heart rate Up to 137 days Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval Up to 137 days QT interval: Measured from the beginning of the QRS complex to the end of the T wave
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval Up to 137 days QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
Incidence of clinically significant changes in inflammatory markers: C-reactive protein (CRP) Up to 137 days Incidence of clinically significant changes in inflammatory markers: Interleukin-6 (IL-6) Up to 137 days Incidence of clinically significant changes in inflammatory markers: Tumor necrosis factor alpha (TNFα) Up to 137 days Incidence of clinically significant changes in clinical laboratory results: Hematology tests Up to 137 days Incidence of clinically significant changes in vital signs: Blood pressure Up to 137 days Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval Up to 137 days QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
Incidence of Adverse Events (AEs) Up to 137 days Incidence of clinically significant changes in inflammatory markers: Interferon-gamma (IFN-γ) Up to 137 days Incidence of clinically significant changes in inflammatory markers: Interleukin-8 (IL-8) Up to 137 days Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests Up to 137 days Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval Up to 137 days PR interval: The time from the onset of the P wave to the start of the QRS complex
Incidence of clinically significant changes in physical examination findings Up to 137 days Incidence of clinically significant changes in inflammatory markers: Interleukin-1 beta (IL-1β) Up to 137 days
- Secondary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax) Up to 137 days Time of maximum observed plasma concentration (Tmax) Up to 137 days Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) Up to 137 days
Trial Locations
- Locations (2)
Medvin Clinical Research - Metyas
🇺🇸Covina, California, United States
Local Institution - 0001
🇩🇪Berlin, Germany