NCT01614756已完成1 期
A Two-Part, Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study of Subcutaneous and Intravenous Administration of IL-31 mAb (Anti-Interleukin 31 Monoclonal Antibody; BMS-981164) in Healthy Subjects and Adult Subjects With Atopic Dermatitis
Bristol-Myers Squibb5 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2012年7月最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 5
- 主要终点
- For both Part 1 and Part 2, the primary endpoint will be based on incident adverse event reports, vital sign measurements, physical (including injection site) examinations, electrocardiograms (ECGs), medical history, and clinical laboratory tests
研究概览
简要总结
The purpose of the study is to determine safety and tolerability of IL-31 mAB
详细描述
Healthy Volunteers not acceptable for "Part 2" (Adult subjects with Atopic Dermatitis)
Enrollment: (both Part 1 and Part 2) Part 2 will consist of up to 42 patients with atopic dermatitis
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
- All
- 接受健康志愿者
- 是
入选标准
- •Part 1: Healthy subjects
- •Part 2: Adult subjects with:
- •Atopic dermatitis severity as assessed by Physician Global Assessment rating of 3 or higher (i.e., moderate or greater) on a scale of 0 to 5
- •Pruritus severity of at least 7 of 10 on a visual analog scale
排除标准
- •Receipt of systemic immunosuppressants, other than biological agents, or topical calcineurin inhibitors (tacrolimus or pimecrolimus) within 4 weeks prior to study drug administration
结局指标
主要结局
For both Part 1 and Part 2, the primary endpoint will be based on incident adverse event reports, vital sign measurements, physical (including injection site) examinations, electrocardiograms (ECGs), medical history, and clinical laboratory tests
时间窗: Up to 16 weeks after single dose
次要结局
- The Maximum observed serum concentration (Cmax) of BMS-981164 will be derived from serum concentration versus time(13 timepoints upto 16 weeks after single dose)
- The Time of maximum observed serum concentration (Tmax) of BMS-981164 will be derived from serum concentration versus time(13 timepoints upto 16 weeks after single dose)
- The Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-981164 will be derived from serum concentration versus time(13 timepoints upto 16 weeks after single dose)
- The Area under the serum concentration-time curve from zero to time of the last quantifiable concentration [AUC(0-T)] of BMS-981164 will be derived from serum concentration versus time(13 timepoints upto 16 weeks after single dose)
- The Terminal serum half-life (T-HALF) of BMS-981164 will be derived from serum concentration versus time(13 timepoints upto 16 weeks after single dose)
- The Apparent volume of distribution at steady state (Vss/F) of BMS-981164 will be derived from serum concentration versus time(13 timepoints upto 16 weeks after single dose)
- The Volume of distribution at steady state (Vss) of BMS-981164 will be derived from serum concentration versus time(13 timepoints upto 16 weeks after single dose)
- The Apparent total body clearance (CLT/F) of BMS-981164 will be derived from serum concentration versus time(13 timepoints upto 16 weeks after single dose)
- The Total body clearance (CLT) of BMS-981164 will be derived from serum concentration versus time(13 timepoints upto 16 weeks after single dose)
- The Absolute bioavailability (F) of BMS-981164 will be derived from serum concentration versus time(13 timepoints upto 16 weeks after single dose)
- Frequency of subjects with one or more positive post-treatment anti-drug antibodies (ADA) assessments(Up to 16 weeks after single dose)
研究者
研究点 (5)
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