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临床试验/NCT01614756
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 Squibb4 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1日最近更新:
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适应症
干预措施

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
4
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
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

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

  • •For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
  • •Inclusion Criteria:
  • •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

研究组 & 干预措施

Dose Escalation- BMS-981164 or Placebo (dose group 3)

Experimental

Part 2

BMS-981164: Solution, Depending on dose level selected could be subcutaneous, ≤ 0.1 mg/kg, once, single dose

OR

Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0 mg, once, single dose

干预措施: BMS-981164 (Biological)

Dose Escalation-BMS-981164 (0.1 mg/kg) or Placebo

Experimental

Part 1

Single dose of BMS-981164 0.1 mg/kg solution subcutaneously

OR

Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously

干预措施: Placebo matching with BMS-981164 (Biological)

Dose Escalation-BMS-981164 (0.01 mg/kg) or Placebo

Experimental

Part 1

Single dose of BMS-981164 0.01 mg/kg solution subcutaneously

OR

Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously

干预措施: Placebo matching with BMS-981164 (Biological)

Dose Escalation-BMS-981164 (0.03 mg/kg) or Placebo

Experimental

Part 1

Single dose of BMS-981164 0.03 mg/kg solution subcutaneously

OR

Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously

干预措施: Placebo matching with BMS-981164 (Biological)

Dose Escalation-BMS-981164 (0.06 mg/kg) or Placebo

Experimental

Part 1

Single dose of BMS-981164 0.06 mg/kg solution subcutaneously

OR

Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously

干预措施: Placebo matching with BMS-981164 (Biological)

Dose Escalation- BMS-981164 (0.1 mg/kg) or Placebo

Experimental

Part 1

Single dose of BMS-981164 0.1 mg/kg solution subcutaneously

OR

Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously

干预措施: Placebo matching with BMS-981164 (Biological)

Dose Escalation-BMS-981164 (0.3 mg/kg) or Placebo

Experimental

Part 1

Single dose of BMS-981164 0.3 mg/kg solution subcutaneously

OR

Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously

干预措施: Placebo matching with BMS-981164 (Biological)

Dose Escalation-BMS-981164 (1 mg/kg SC) or Placebo

Experimental

Part 1

Single dose of BMS-981164 1 mg/kg solution subcutaneously

OR

Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously

干预措施: Placebo matching with BMS-981164 (Biological)

Dose Escalation-BMS-981164 (1 mg/kg IV) or Placebo

Experimental

Part 1

Single dose of BMS-981164 1 mg/kg solution intravenously

OR

Single dose of Placebo matching with BMS-981164 0 mg/kg solution intravenously

干预措施: Placebo matching with BMS-981164 (Biological)

Dose Escalation-BMS-981164 (3 mg/kg IV) or Placebo

Experimental

Part 1

Single dose of BMS-981164 3 mg/kg solution intravenously

OR

Single dose of Placebo matching with BMS-981164 0 mg/kg solution intravenously

干预措施: Placebo matching with BMS-981164 (Biological)

Dose Escalation-BMS-981164 (10 mg/kg IV) or Placebo

Experimental

Part 1

Single dose of BMS-981164 10.0 mg/kg solution intravenously

OR

Single dose of Placebo matching with BMS-981164 0 mg/kg solution intravenously

干预措施: Placebo matching with BMS-981164 (Biological)

Dose Escalation- BMS-981164 or Placebo (dose group 1)

Experimental

Part 2

BMS-981164: Solution, Depending on dose level selected could be subcutaneous or IV, 3 mg/kg, once, single dose

OR

Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous or IV, 0 mg, once, single dose

干预措施: Placebo matching with BMS-981164 (Biological)

Dose Escalation- BMS-981164 or Placebo (dose group 2)

Experimental

Part 2

BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0.1 mg/kg, once, single dose

OR

Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0 mg, once, single dose

干预措施: Placebo matching with BMS-981164 (Biological)

Dose Escalation- BMS-981164 or Placebo (dose group 3)

Experimental

Part 2

BMS-981164: Solution, Depending on dose level selected could be subcutaneous, ≤ 0.1 mg/kg, once, single dose

OR

Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0 mg, once, single dose

干预措施: Placebo matching with BMS-981164 (Biological)

Dose Escalation- BMS-981164 or Placebo (dose group 4)

Experimental

Part 2

BMS-981164: Solution, Depending on dose level selected could be subcutaneous, ≤ 3.0 mg/kg and >1.0mg/kg, once, single dose

OR

Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0 mg, once, single dose

干预措施: Placebo matching with BMS-981164 (Biological)

Dose Escalation-BMS-981164 (0.06 mg/kg) or Placebo

Experimental

Part 1

Single dose of BMS-981164 0.06 mg/kg solution subcutaneously

OR

Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously

干预措施: BMS-981164 (Biological)

Dose Escalation- BMS-981164 (0.1 mg/kg) or Placebo

Experimental

Part 1

Single dose of BMS-981164 0.1 mg/kg solution subcutaneously

OR

Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously

干预措施: BMS-981164 (Biological)

Dose Escalation-BMS-981164 (10 mg/kg IV) or Placebo

Experimental

Part 1

Single dose of BMS-981164 10.0 mg/kg solution intravenously

OR

Single dose of Placebo matching with BMS-981164 0 mg/kg solution intravenously

干预措施: BMS-981164 (Biological)

Dose Escalation-BMS-981164 (3 mg/kg IV) or Placebo

Experimental

Part 1

Single dose of BMS-981164 3 mg/kg solution intravenously

OR

Single dose of Placebo matching with BMS-981164 0 mg/kg solution intravenously

干预措施: BMS-981164 (Biological)

Dose Escalation-BMS-981164 (1 mg/kg IV) or Placebo

Experimental

Part 1

Single dose of BMS-981164 1 mg/kg solution intravenously

OR

Single dose of Placebo matching with BMS-981164 0 mg/kg solution intravenously

干预措施: BMS-981164 (Biological)

Dose Escalation-BMS-981164 (1 mg/kg SC) or Placebo

Experimental

Part 1

Single dose of BMS-981164 1 mg/kg solution subcutaneously

OR

Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously

干预措施: BMS-981164 (Biological)

Dose Escalation-BMS-981164 (0.3 mg/kg) or Placebo

Experimental

Part 1

Single dose of BMS-981164 0.3 mg/kg solution subcutaneously

OR

Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously

干预措施: BMS-981164 (Biological)

Dose Escalation-BMS-981164 (0.03 mg/kg) or Placebo

Experimental

Part 1

Single dose of BMS-981164 0.03 mg/kg solution subcutaneously

OR

Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously

干预措施: BMS-981164 (Biological)

Dose Escalation-BMS-981164 (0.01 mg/kg) or Placebo

Experimental

Part 1

Single dose of BMS-981164 0.01 mg/kg solution subcutaneously

OR

Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously

干预措施: BMS-981164 (Biological)

Dose Escalation-BMS-981164 (0.1 mg/kg) or Placebo

Experimental

Part 1

Single dose of BMS-981164 0.1 mg/kg solution subcutaneously

OR

Single dose of Placebo matching with BMS-981164 0 mg/kg solution subcutaneously

干预措施: BMS-981164 (Biological)

Dose Escalation- BMS-981164 or Placebo (dose group 4)

Experimental

Part 2

BMS-981164: Solution, Depending on dose level selected could be subcutaneous, ≤ 3.0 mg/kg and >1.0mg/kg, once, single dose

OR

Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0 mg, once, single dose

干预措施: BMS-981164 (Biological)

Dose Escalation- BMS-981164 or Placebo (dose group 2)

Experimental

Part 2

BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0.1 mg/kg, once, single dose

OR

Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous, 0 mg, once, single dose

干预措施: BMS-981164 (Biological)

Dose Escalation- BMS-981164 or Placebo (dose group 1)

Experimental

Part 2

BMS-981164: Solution, Depending on dose level selected could be subcutaneous or IV, 3 mg/kg, once, single dose

OR

Placebo matching with BMS-981164: Solution, Depending on dose level selected could be subcutaneous or IV, 0 mg, once, single dose

干预措施: BMS-981164 (Biological)

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 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)
  • 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)
  • 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

发起方
Bristol-Myers Squibb
申办方类型
Industry
责任方
Sponsor

研究点 (4)

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