NCT02101073已完成1 期
A Phase I, Open-Label Study Evaluating the Bioavailability of ALX-0061 After Subcutaneous and Intravenous Administration in Healthy Volunteers.
Ablynx, a Sanofi company1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2014年3月31日最近更新:
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
- 70
- 试验地点
- 1
- 主要终点
- Pharmacokinetics: serum concentration of ALX-0061 after single subcutaneous (s.c.) and single intravenous (i.v.) doses of ALX-0061 in healthy volunteers
研究概览
简要总结
The overall aims of the study are:
- To assess the bioavailability of single doses of ALX-0061, administered s.c. at three dose levels, using 2 corresponding single i.v. dose levels as reference.
- To provide additional information on pharmacokinetics and pharmacodynamics of ALX-0061.
- To further determine the safety and tolerability of ALX-0061.
- To further evaluate the systemic (serum) immunogenicity of ALX-0061.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers.
- •Gender: male or female.
- •Age 18 to 55 years.
- •Body mass index (BMI): 18.0 ≥ BMI < 30.0 kg/m
排除标准
- •Any active inflammatory condition, or autoimmune disorder such as lupus erythematosus, multiple sclerosis or rheumatoid arthritis (RA).
- •Any current or recent (within 4 weeks prior to dose) signs or symptoms of infection that requires parenteral antibiotic administration.
- •Symptomatic infection, or suspicion thereof in the last 1 week prior to dosing.
研究组 & 干预措施
ALX-0061 low dose i.v.
Experimental
干预措施: ALX-0061 (Biological)
ALX-0061 high dose s.c.
Experimental
干预措施: ALX-0061 (Biological)
ALX-0061 middle dose s.c.
Experimental
干预措施: ALX-0061 (Biological)
ALX-0061 low dose s.c.
Experimental
干预措施: ALX-0061 (Biological)
ALX-0061 high dose i.v.
Experimental
干预措施: ALX-0061 (Biological)
结局指标
主要结局
Pharmacokinetics: serum concentration of ALX-0061 after single subcutaneous (s.c.) and single intravenous (i.v.) doses of ALX-0061 in healthy volunteers
时间窗: Day 1 to Day 32 +/- 2 days after dosing for low dose treatment arms, Day 1 to Day 46 +/-2 days after dosing for middle dose treatment arm, Day 1 to Day 53 +/- 2 days after dosing for high dose treatment arms
次要结局
- Immunogenicity: concentration of Anti-Drug Antibodies (ADA) in serum(From screening until final visit (i.e. 60+/- 2 days after dosing for the low dose and middle dose treatment arms and 83 +/- 2 days after dosing for the high dose treatment arms)
- Pharmacodynamics: concentration in plasma of total soluble Interleukin-6 receptor (sIL-6R) and in serum of IL-6(During screening untill final visit (i.e. 60 +/- 2 days after dosing for the low dose and middle dose treatment arms and 83 +/- 2 days after dosing for the high dose treatment arms))
- Safety and tolerability: safety markers(From signing of informed consent until final visit (i.e. 60 +/- 2 days for the low dose and middle dose treatment arms and 83 +/- 2 days for the high dose treatment arms)
研究者
研究点 (1)
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