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
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 118
- 试验地点
- 4
- 主要终点
- Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
时间窗: Up to 137 days
Incidence of clinically significant changes in vital signs: Body temperature
时间窗: Up to 137 days
Incidence of clinically significant changes in vital signs: Respiratory rate
时间窗: Up to 137 days
Incidence of clinically significant changes in vital signs: Heart rate
时间窗: Up to 137 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
时间窗: 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
时间窗: 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)
时间窗: Up to 137 days
Incidence of clinically significant changes in inflammatory markers: Interleukin-6 (IL-6)
时间窗: Up to 137 days
Incidence of clinically significant changes in inflammatory markers: Tumor necrosis factor alpha (TNFα)
时间窗: Up to 137 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
时间窗: Up to 137 days
Incidence of clinically significant changes in vital signs: Blood pressure
时间窗: Up to 137 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
时间窗: 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)
时间窗: Up to 137 days
Incidence of clinically significant changes in inflammatory markers: Interferon-gamma (IFN-γ)
时间窗: Up to 137 days
Incidence of clinically significant changes in inflammatory markers: Interleukin-8 (IL-8)
时间窗: Up to 137 days
Incidence of clinically significant changes in inflammatory markers: Interleukin-1 beta (IL-1β)
时间窗: Up to 137 days
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
时间窗: Up to 137 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
时间窗: 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
时间窗: Up to 137 days
次要结局
- 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)