A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of Intravenously Administered BMS-986168 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Safety and tolerability, as measured by incidence of AEs, serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, and physical and neurological examinations.
研究概览
简要总结
This is a randomized, double-blind, placebo controlled, single ascending dose escalation, safety, tolerability, PK, PD and immunogenicity study of BMS-986168 administered by an intravenous infusion in healthy subjects.
详细描述
This study, previously posted by Bristol-Myers Squibb, has transitioned to Biogen under a licensing agreement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects, who have no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations.
- •Body Mass Index (BMI) of 18.5-30 kg/m^2, inclusive. BMI=weight (kg)/[height(m)]^
- •Males and Females, not of child-bearing potential, ages 21 to 65 years, inclusive. Female subjects must have documented proof that they are not of childbearing potential.
- •Male subjects must be willing to use effective birth control and refrain from sperm donation during the entire study and for 200 days after dosing has been completed.
排除标准
- •Women who are of childbearing potential or breastfeeding.
- •Any significant acute or chronic medical illness.
- •Any history of cancer within 5 years of enrollment.
- •Any major surgery within 4 weeks of study drug administration.
- •Donation of blood or serum > 500 mL to a blood bank or in a clinical study (except screening visit) within 3 months of study drug administration.
- •Participation in a clinical study (except a screening visit) within 4 weeks (or 5 half lives, whichever is longer), of study drug administration.
- •Inability to be venipunctured and/or tolerate venous access.
- •Has smoked or used tobacco products within 6 months prior to study drug administration.
- •Recent (within 6 months of study drug administration) drug or alcohol abuse as defined in DSM IV, Diagnostic Criteria for Drug and Alcohol Abuse
研究组 & 干预措施
Single Ascending dose cohorts
Single ascending dose escalation, safety, tolerability, PK, PD and immunogenicity study of BMS-986168 administered by an intravenous infusion in healthy subjects.
干预措施: BMS-986168 (Drug)
Placebo
BMS-986168 Placebo
干预措施: BMS-986168 Placebo (Drug)
结局指标
主要结局
Safety and tolerability, as measured by incidence of AEs, serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, and physical and neurological examinations.
时间窗: 8 months
To evaluate the safety and tolerability of a single intravenous (IV) infusion of BMS-986168 in healthy subjects.
次要结局
未报告次要终点