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临床试验/NCT02106897
NCT02106897已完成1 期

A Single-Ascending-Dose and Multiple-Ascending-Dose Study of BIIB059 in Healthy Volunteers and Subjects With Systemic Lupus Erythematosus

Biogen1 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2014年4月30日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
Biogen
入组人数
109
试验地点
1
主要终点
Number of Participants that Experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
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 primary objective of Parts 1 and 2 is to evaluate the safety and tolerability of either single-ascending intravenous (IV) doses or a single subcutaneous (SC) dose of BIIB059 (litifilimab) in healthy volunteers (HV), and a single IV dose in participants with Systemic Lupus Erythematosus (SLE). The primary objective of Part 3 is to evaluate the safety and tolerability of multiple SC doses of BIIB059 in healthy volunteers and in participants with SLE.

Secondary objectives of Parts 1 and 2 are as follows: To estimate the PK parameters of single-ascending IV doses of BIIB059 in healthy volunteers and a single IV dose of BIIB059 in participants with SLE; To estimate the PK parameters and bioavailability (F) of a single SC dose of BIIB059 in healthy volunteers; To evaluate the immunogenicity of BIIB059 administered to healthy volunteers and participants with SLE. Secondary objectives of Part 3 are as follows: To estimate the PK parameters of multiple SC doses of BIIB059 in healthy volunteers and in participants with SLE; To evaluate the immunogenicity of BIIB059 administered SC to healthy volunteers and participants with SLE.

详细描述

Part 1 (single ascending dose in healthy volunteers) has closed to enrollment.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Part 1, Cohort 1: BIIB059 0.05 mg/kg IV

Experimental

BIIB059 0.05 mg/kg IV dose, Once on Day 1

干预措施: BIIB059 (litifilimab) (Drug)

Part 1, Cohort 2: BIIB059 0.3 mg/kg IV

Experimental

BIIB059 0.3 mg/kg IV dose, Once on Day 1

干预措施: BIIB059 (litifilimab) (Drug)

Part 1, Cohort 3: BIIB059 1 mg/kg IV

Experimental

BIIB059 1 mg/kg IV dose, Once on Day 1

干预措施: BIIB059 (litifilimab) (Drug)

Part 1, Cohort 4: BIIB059 3 mg/kg IV

Experimental

BIIB059 3 mg/kg IV dose, Once on Day 1

干预措施: BIIB059 (litifilimab) (Drug)

Part 1, Cohort 5: BIIB059 10 mg/kg IV

Experimental

BIIB059 10 mg/kg IV dose, Once on Day 1

干预措施: BIIB059 (litifilimab) (Drug)

Part 1, Cohort 6: BIIB059 20 mg/kg IV

Experimental

BIIB059 20 mg/kg IV dose, Once on Day 1

干预措施: BIIB059 (litifilimab) (Drug)

Part 1, Cohort 7: BIIB059 50 mg SC

Experimental

BIIB059 50 mg SC dose, Once on Day 1

干预措施: BIIB059 (litifilimab) (Drug)

Part 1, Cohort 1-6: Placebo IV

Placebo Comparator

Matching placebo IV dose, Once on Day 1

干预措施: Placebo (Drug)

Part 1, Cohort 7: Placebo SC

Placebo Comparator

Matching placebo SC dose, Once on Day 1

干预措施: Placebo (Drug)

Part 2, Cohort 8: BIIB059 20 mg/kg IV

Experimental

BIIB059 20 mg/kg IV dose, Once on Day 1

干预措施: BIIB059 (litifilimab) (Drug)

Part 2, Cohort 8: Placebo IV

Placebo Comparator

Matching placebo IV dose, Once on Day 1

干预措施: Placebo (Drug)

Part 3a, Cohort 9: BIIB059 20 mg SC

Experimental

BIIB059 20 mg SC dose, Every 4 weeks for 2 doses

干预措施: BIIB059 (litifilimab) (Drug)

Part 3a, Cohort 10: BIIB059 50 mg SC

Experimental

BIIB059 50 mg SC dose, Every 4 weeks for 2 doses

干预措施: BIIB059 (litifilimab) (Drug)

Part 3a, Cohort 11: BIIB059 150 mg SC

Experimental

BIIB059 150 mg SC dose, Every 4 weeks for 2 doses

干预措施: BIIB059 (litifilimab) (Drug)

Part 3a, Cohort 12: BIIB059 300 mg or less SC

Experimental

BIIB059 300 mg or less SC dose, Every 2 weeks for 3 doses

干预措施: BIIB059 (litifilimab) (Drug)

Part 3a, Cohort 9-12: Placebo SC

Placebo Comparator

Matching placebo SC dose, Every 4 weeks for 2 doses or every 2 weeks for 3 doses

干预措施: Placebo (Drug)

Part 3b, Cohort 13: BIIB059 50 mg SC

Experimental

BIIB059 50 mg SC dose, Every 4 weeks for 2 doses

干预措施: BIIB059 (litifilimab) (Drug)

Part 3b, Cohort 14: BIIB059 300 mg or less SC

Experimental

BIIB059 300 mg or less SC dose, Every 2 weeks for 3 doses

干预措施: BIIB059 (litifilimab) (Drug)

Part 3b, Cohort 13-14: Placebo SC

Placebo Comparator

Matching placebo SC dose, Every 4 weeks for 2 doses or every 2 weeks for 3 doses

干预措施: Placebo (Drug)

结局指标

主要结局

Number of Participants that Experience Adverse Events (AEs) and Serious Adverse Events (SAEs)

时间窗: Up to Week 32

次要结局

  • Apparent Clearance (CL/F) of BIIB059(Up to Week 32)
  • Time to Reach Maximum Observed Concentration (Tmax) of BIIB059(Up to Week 32)
  • Terminal Elimination Half-Life (t1/2) of BIIB059(Up to Week 32)
  • Clearance (CL) of BIIB059(Up to Week 32)
  • Volume of Distribution (Vss) of BIIB059(Up to Week 32)
  • Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUCinf) of BIIB059(Up to Week 32)
  • Maximum Observed Concentration (Cmax) of BIIB059(Up to Week 32)
  • Apparent Volume of Distribution (Vz/F) of BIIB059(Up to Week 32)
  • Bioavailability (F) for a single SC dose of BIIB059(Up to Week 32)
  • Number of Participants Who Develop Serum Anti-BIIB059 Antibodies(Up to Week 32)
  • Absorption Rate Profile for a Single SC Dose of BIIB059(Up to Week 32)

研究者

发起方
Biogen
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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