NCT01537640已完成1 期
A Randomized, Double-Blind, Parallel Group Study of the Pharmacokinetics, Safety, and Tolerability of Two Different SAR231893 Drug Products After Administration of a Single Subcutaneous Dose to Healthy Subjects
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assessment of serum concentrations of SAR231893 (REGN668)
研究概览
简要总结
Primary Objective:
To determine and compare the pharmacokinetic (PK) profiles of 2 different SAR231893 (REGN668) drug products after administration of a single subcutaneous (SC) dose
Secondary Objective:
To determine and compare the safety and tolerability of the 2 SAR231893 (REGN668) drug products after administration of a single SC dose
详细描述
The duration of the study for each subject is 8-11 weeks broken down as follows:
- Screening: 2 to 21 days,
- Treatment: 1 day (2 overnight stays at the study site),
- Follow-up: up to 2 months after dosing.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects between 18 and 45 years of age
排除标准
- •Presence or history of drug hypersensitivity or allergic disease
- •History or presence of dermatological disorders
- •Fever or persistent chronic or active recurring infection requiring treatment within 4 weeks prior to screening, or history of frequent recurrent infections
- •Prior opportunistic infections within 6 months before inclusion
- •History or presence of listeriosis or tuberculosis
- •Any vaccination within 3 months (1 month for influenza vaccine) before inclusion
- •Any biologics given within 4 months before inclusion
- •Recent history of a parasitic infection or travel to a parasitic endemic area within 6 months prior to screening
- •The above information is not intended to contain all considerations relevant to a subject's potential participation in a clinical trial.
研究组 & 干预措施
SAR231893 (REGN668) Drug Product (DP) 1
Experimental
SAR231893 (REGN668) Drug Product 1 in a single subcutaneous injection
干预措施: SAR231893 (REGN668) DP1 (Biological)
SAR231893 (REGN668) Drug Product (DP) 2
Experimental
SAR231893 (REGN668) Drug Product 2 in a single subcutaneous injection
干预措施: SAR231893 (REGN668) DP2 (Biological)
结局指标
主要结局
Assessment of serum concentrations of SAR231893 (REGN668)
时间窗: Up to 57 Days
次要结局
- Number of participants experiencing adverse events(Up to 57 Days)
- Pain evaluation at injection site using Visual Analog Scale (VAS)(Up to 8 Days)
- Erythema at injection site by measuring diameter(Up to 8 Days)
- Edema at injection site by measuring diameter(Up to 8 Days)
研究者
研究点 (1)
Loading locations...
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