NCT01620931已完成1 期
A Single-Center, Randomized, Observer-Blinded, Placebo-Controlled, Single-Ascending-Dose (SAD) Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5469754, a Humanized Monoclonal Antibody, Following Intravenous or Subcutaneous Administration in Healthy Adults
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
- 36
- 主要终点
- Safety: Incidence of adverse events
研究概览
简要总结
This randomized, observer-blinded, placebo-controlled study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5469754 in healthy volunteers. Subjects will be randomized in cohorts to receive single ascending intravenous or subcutaneous doses of RO5469754 or placebo. In-clinic period will be from Day -1 to Day 4, with a safety follow-up of 15 weeks 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
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female volunteers, 18 to 64 years of age, inclusive
- •Body mass index (BMI) 18 to 32 kg/m2
- •Women of child-bearing potential and their partners must be willing to use two highly effective forms of contraception, one of which must be a barrier method, for the entire duration of the study (through study discharge) or for up to five half-lives after the last dose
- •Male subjects with female partners of child-bearing potential must be willing to use a condom during sexual activity for the duration of the study (through study discharge) or for up to five half-lives after the last dose
排除标准
- •Pregnant or lactating women
- •Positive test for drugs of abuse (including ethanol) as per local standards
- •Willing to comply with a non-smoking policy during the in-clinic part of the study (Day -1 until discharge on Day 4)
- •Positive for hepatitis B, hepatitis C or HIV infection
- •History or presence of clinically significant disease or condition
- •Participation in an investigational drug or device study within 60 days prior to dosing
- •Current (or previous history of) exposure to therapeutic or investigational monoclonal antibody or chimeric biomolecule
- •Any confirmed clinically significant previous allergic drug reaction, or history of anaphylaxis
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
RO5469754
Experimental
干预措施: RO5469754 (Drug)
结局指标
主要结局
Safety: Incidence of adverse events
时间窗: approximately 1 year
次要结局
- Pharmacokinetics: Area under the concentration-time curve (AUC)(Pre-dose and up to 72/120 hours post-dose, and at follow-up)
研究者
相似试验
已完成
1 期
This Study Will Investigate the Safety, Tolerability and Pharmacokinetic Profile of Repeat Oral Doses of GSK2140944 in Healthy Adult SubjectsInfections, Respiratory TractNCT01706315GlaxoSmithKline72
已完成
1 期
A Study on Safety, Pharmacokinetics and Pharmacodynamics of RO5508887 in Healthy VolunteersHealthy VolunteerNCT01461967Hoffmann-La Roche49
已完成
1 期
A Single-Center Study of RO5508887 in Healthy VolunteersHealthy VolunteerNCT01664143Hoffmann-La Roche36
已完成
1 期
A Study of RO4989991 in Patients With Allergic RhinitisAsthmaNCT01152619Hoffmann-La Roche24
已完成
1 期
A Study of RO5024048 in Japanese and Caucasian Healthy VolunteersHealthy VolunteerNCT01152671Hoffmann-La Roche97