Double-Blind, Randomized, Placebo-Controlled, Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Target Engagement of BMS-986184 in Healthy Subjects and to Evaluate the Safety, Efficacy, Pharmacokinetics, Target Engagement, and Pharmacodynamics of BMS-986184 in Patients With Moderate to Severe Ulcerative Colitis
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Composite of safety and tolerability of BMS-986184 as assessed by vital sign measurements
研究概览
简要总结
The primary purpose of this study is to determine if single and multiple doses of BMS-986184 are safe and well tolerated in healthy male and female subjects. The primary purpose of the proof of mechanism study is to determine safety and efficacy in patients with ulcerative colitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Investigator)
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
- •Women of childbearing potential must have a negative serum pregnancy test within 24 hours prior to the start of study drug
- •Diagnosis of ulcerative colitis confirmed by endoscopic and histologic evidence (if no previous confirmation of diagnosis is available or if diagnosis is not conclusive, at time of baseline endoscopy, histology must be performed and read locally to confirm diagnosis)
排除标准
- •Any bacterial, fungal or viral infection, including tuberculosis, HIV, hepatitis B or hepatitis C
- •Subjects with history of cancer, lymphoproliferative disease, class III or IV congestive heart failure, myocardial infarction, unstable angina pectoris, or any history of significant ocular disease such as glaucoma or retinal disease
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Single Ascending Dose (SAD) - IV Panel
Single intravenous (IV) dose of BMS-986184 or placebo matching BMS-986184
干预措施: BMS-986184 (Drug)
Single Ascending Dose (SAD) - IV Panel
Single intravenous (IV) dose of BMS-986184 or placebo matching BMS-986184
干预措施: Placebo matching BMS-986184 (Drug)
Single Ascending Dose (SAD) - SC Panel
Single subcutaneous (SC) dose of BMS-986184 or placebo matching BMS-986184
干预措施: BMS-986184 (Drug)
Single Ascending Dose (SAD) - SC Panel
Single subcutaneous (SC) dose of BMS-986184 or placebo matching BMS-986184
干预措施: Placebo matching BMS-986184 (Drug)
Multiple Ascending Dose (MAD) - IV Panel
Multiple IV doses of BMS-986184 or placebo matching BMS-986184
干预措施: BMS-986184 (Drug)
Multiple Ascending Dose (MAD) - IV Panel
Multiple IV doses of BMS-986184 or placebo matching BMS-986184
干预措施: Placebo matching BMS-986184 (Drug)
Proof of Mechanism (POM) - IV Panel
Multiple IV doses of BMS-986184 or placebo matching BMS-986184
干预措施: BMS-986184 (Drug)
Proof of Mechanism (POM) - IV Panel
Multiple IV doses of BMS-986184 or placebo matching BMS-986184
干预措施: Placebo matching BMS-986184 (Drug)
结局指标
主要结局
Composite of safety and tolerability of BMS-986184 as assessed by vital sign measurements
时间窗: Up to 183 days
Composite of safety and tolerability of BMS-986184 as assessed by physical examination findings
时间窗: Up to 183 days
Composite of safety and tolerability of BMS-986184 as assessed by clinical laboratory test results
时间窗: Up to 183 days
Composite of safety and tolerability of BMS-986184 as assessed by Electrocardiogram (ECG) assessments
时间窗: Up to 183 days
Composite of incidence, severity and outcome of all Adverse Events (AEs)
时间窗: Up to 183 days
次要结局
未报告次要终点