A Study of RG7625 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 主要终点
- Safety (composite outcome measure):Incidence and severity of adverse events (AEs), laboratory abnormalities, changes in ECG, vital signs
研究概览
简要总结
This is a single center, randomized, double-blind, placebo-controlled, single ascending dose study that will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of single doses of RG7625 in healthy male and female volunteers.
The study will employ an interleaved cohort ('leapfrog') design in which dosing is alternated between two cohorts and each individual within a cohort will receive study drug dosing on four occasions - in effect giving a four treatment, four period, four-way crossover for each individual. The minimum duration for each participant is approximately 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female participants, 18 to 60 years of age, inclusive
- •A body mass index between 18 to 30 kg/m2 inclusive
- •Able to participate and willing to give written informed consent and to comply with the study restrictions
排除标准
- •Any clinically relevant abnormalities, concomitant diseases or ongoing medical conditions, abnormal laboratory test results or a history of any other clinically significant disorders
- •Any major illness within the one month preceding the screening visit, or any febrile illness within the two weeks preceding the screening visit
- •Any significant allergic reaction to drugs
- •Immunocompromised or with reduced immune function and/or immunization within 30 days before the first study drug administration or planning vaccination during the study
- •Women who are pregnant or lactating or of childbearing potential
- •Clinically significant abnormal ECG or other risk factors for QT prolongation
- •Use of prescribed or over the counter medication
- •Inability or unwillingness to comply with study requirements
研究组 & 干预措施
Cohort B
干预措施: RG7625 (Drug)
Cohort A
干预措施: Placebo (Drug)
Cohort A
干预措施: RG7625 (Drug)
Cohort B
干预措施: Placebo (Drug)
结局指标
主要结局
Safety (composite outcome measure):Incidence and severity of adverse events (AEs), laboratory abnormalities, changes in ECG, vital signs
时间窗: Approximately 22 weeks
次要结局
- Pharmacodynamics (composite outcome measure): measurement of intracellular p10 concentrations and cell surface expression of major histocompatibility complex class (MHC)-II, relationship to RG7625 exposure(22 weeks)
- Pharmacokinetics (composite outcome measure): PK profile and parameters derived from plasma concentrations of RG7625 and its metabolites [AUCinf, AUClast, Cmax, tmax, t1/2, CL/F, V/F, Ae, fe and CLR](22 weeks)