Assessment of the Safety, Tolerability, and Pharmacokinetics of ABT-199 After Single and Multiple Ascending Doses in Female Subjects With Systemic Lupus Erythematosus (SLE)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 97
- 试验地点
- 15
- 主要终点
- Number of participants with Adverse Events
研究概览
简要总结
To assess the safety, tolerability and pharmacokinetics of ABT-199 in female subjects with Systemic Lupus Erythematosus.
详细描述
This is a phase 1, randomized, double-blind, placebo-controlled, single-and multiple ascending dose study. Up to eighty-eight subjects with Systemic Lupus Erythematosus will be selected to participate. Subjects will be randomized to receive either ABT-199 or placebo. Subjects will be administered ABT-199/placebo as a single dose or up to 14 days as multiple doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of systemic lupus erythematosus for at least 6 months.
- •Documentation of at least one of the following: ANA titer >= 1:160 or positive anti-dsDNA antibodies.
- •Stable systemic lupus erythematosus medication regimen.
- •Other than systemic lupus erythematosus, subject should be in general good health.
排除标准
- •Drug-induced or highly active systemic lupus erythematosus.
- •Significant autoimmune disease other than lupus.
- •Significant, uncontrolled or unstable disease in any organ.
研究组 & 干预措施
Single Dose
Subjects enrolled in the Single Ascending Dose (SAD) part of the study will receive a single dose of study drug or placebo. (Groups 1, 2, 3, 4, 5 and 6).
干预措施: ABT-199 (Drug)
Single Dose
Subjects enrolled in the Single Ascending Dose (SAD) part of the study will receive a single dose of study drug or placebo. (Groups 1, 2, 3, 4, 5 and 6).
干预措施: Placebo (Other)
Multiple Dose
Subjects enrolled in the Multiple Ascending Dose (MAD) part of the study will receive multiple doses of study drug or placebo. (Groups 7, 8, 9, 10 and 11)
干预措施: ABT-199 (Drug)
Multiple Dose
Subjects enrolled in the Multiple Ascending Dose (MAD) part of the study will receive multiple doses of study drug or placebo. (Groups 7, 8, 9, 10 and 11)
干预措施: Placebo (Other)
结局指标
主要结局
Number of participants with Adverse Events
时间窗: From first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199
Collect all adverse events at each visit
Physical Exam including vital signs
时间窗: Prior to the first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199
Blood pressure, heart rate and body temperature
Clinical Lab Testing
时间窗: Prior to the first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199
Hematology, Chemistry, and Urinalysis
Maximum observed serum concentration (Cmax) of ABT-199
时间窗: For 72 hours after a single dose of ABT-199 and for 24 hours after the seventh dose of multiple doses of ABT-199
Cmax
Electrocardiogram (ECG) Measurements
时间窗: For 24 hours after a single dose of ABT-199 and up to 24 hours after the seventh dose of multiple doses of ABT-199
ECGs done in triplicate
Time to Cmax (Tmax) of ABT-199
时间窗: For 72 hours after a single dose of ABT-199 and for 24 hours after the seventh dose of multiple doses of ABT-199
Time to Cmax
The area under the time curve (AUC) of ABT-199
时间窗: For 72 hours after a single dose of ABT-199 and for 24 hours after the seventh dose of multiple doses of ABT-199
the area under the exposure-time curve of ABT-199 extrapolated to infinite time for single doses and up to 24 hrs for multiple doses of ABT-199
The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-199
时间窗: For 72 hours after a single dose of ABT-199
The terminal phase elimination rate constant and the terminal elimination half-life (t1/2) of ABT-199
次要结局
- Measurement of lymphocyte depletion and recovery(Prior to the first dose of ABT-199 until 28 days after single dose of ABT-199 and until 21 days after the last multiple dose of ABT-199)