A Double-Blind, Placebo-Controlled, Randomized, Single and Multiple Dose Study on the Safety, Pharmacokinetics, and Exploratory Pharmacodynamics of Subcutaneous and Intravenous BMS-986325 Administration in Healthy Participants and Participants With Primary Sjögren's Syndrome
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy Participants
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 118
- Locations
- 2
- Primary Endpoint
- Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time Frame: Up to 137 days
Incidence of clinically significant changes in vital signs: Body temperature
Time Frame: Up to 137 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Time Frame: Up to 137 days
Incidence of clinically significant changes in vital signs: Heart rate
Time Frame: Up to 137 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
Time Frame: 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
Time Frame: 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)
Time Frame: Up to 137 days
Incidence of clinically significant changes in inflammatory markers: Interleukin-6 (IL-6)
Time Frame: Up to 137 days
Incidence of clinically significant changes in inflammatory markers: Tumor necrosis factor alpha (TNFα)
Time Frame: Up to 137 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time Frame: Up to 137 days
Incidence of clinically significant changes in vital signs: Blood pressure
Time Frame: Up to 137 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
Time Frame: 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)
Time Frame: Up to 137 days
Incidence of clinically significant changes in inflammatory markers: Interferon-gamma (IFN-γ)
Time Frame: Up to 137 days
Incidence of clinically significant changes in inflammatory markers: Interleukin-8 (IL-8)
Time Frame: Up to 137 days
Incidence of clinically significant changes in inflammatory markers: Interleukin-1 beta (IL-1β)
Time Frame: Up to 137 days
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time Frame: Up to 137 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
Time Frame: 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
Time Frame: Up to 137 days
Secondary Outcomes
- 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)