NCT01496755已完成1 期
A Phase I Randomized, Double-Blind, Placebo-Controlled Trial of Single and Multiple Doses of RG7667 in Healthy Adult Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 170
- 主要终点
- Safety: Incidence of adverse events
研究概览
简要总结
This randomized, double-blind, placebo-controlled study will evaluate the safety and pharmacokinetics of RG7667 in healthy volunteers. Subjects will be randomized in cohorts to receive either single/multiple doses of RG7667 intravenously or placebo. Anticipated time on study treatment is up to 57 days with a 12-week follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
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
- •Male and female subjects, 18 to 55 years of age, inclusive
- •Body mass index 18.0 to 31.0 kg/m2, inclusive
- •In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital signs, and laboratory values, as deemed by the Investigator
排除标准
- •History of malignancy, except completely excised basal cell carcinoma or squamous cell carcinoma of the skin or cervical carcinoma in situ
- •History of severe bacterial, fungal, or parasitic infections (more than 2 hospitalizations within 1 year or more than 2 courses of iv antibiotics within 1 year)
- •Pregnant, lactating, or planned pregnancy within 6 months of Screening
- •Positive for hepatitis B, hepatitis C or HIV infection
- •Exposure to any investigational biological agent within 90 days prior to the Screening evaluation or received any other investigational treatment 30 days prior to the Screening evaluation (or within 5 half-lives of the investigational agent, whichever is greater)
- •History of alcoholism or drug addiction within 1 year of Screening
- •Positive urine test for selected drugs of abuse at Screening and Check-in (Day -1); positive breathalyzer test for alcohol at Check-in
- •Use of prescription drugs within 14 days prior to Day 1 or during the study, except for hormonal contraceptives or hormone replacement therapy
- •Use of over-the-counter (OTC) medication within 7 days prior to Day 1 or during the study. Medications such as acetaminophen and ibuprofen and routinely-taken dietary supplements, including vitamins and herbal supplements are allowed at the discretion of the investigator and Sponsor.
- •Donation of plasma within 7 days prior to Day
- •Donation or loss of blood of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to Day
- •Lack of peripheral venous access
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
RG7667
Experimental
干预措施: RG7667 (Drug)
结局指标
主要结局
Safety: Incidence of adverse events
时间窗: up to 141 days
次要结局
- Pharmacokinetic: Time to maximum serum concentration (tmax)(up to 141 days)
- Pharmacokinetic: Apparent clearance (CL/F)(up to 141 days)
- Pharmacokinetic: Terminal half-life (t½)(up to 141 days)
- Pharmacokinetics: Area under the concentration-time curve (AUC)(up to 141 days)
- Pharmacokinetic: Maximum serum concentration (Cmax)(up to 141 days)
研究者
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