A Randomized, Sponsor-Open, Investigator-Blinded, Subject-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7020531 and Metabolites Following Oral Administration to Chinese Healthy Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Adverse Events (AEs)
研究概览
简要总结
To evaluate the safety and tolerability of single and multiple ascending doses of oral RO7020531 in Chinese healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Multiple Ascending Dose (MAD): Placebo
In MAD Cohorts 1-3, there will be six participants in total receiving placebo, two in each cohort.
干预措施: Placebo (Drug)
MAD: Cohorts 2 and 3
Sixteen participants will be administered 150mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
干预措施: RO7020531 (Drug)
Single Ascending Dose (SAD): Placebo
In SAD Cohorts 1-4, there will be eight participants in total receiving placebo, two in each cohort.
干预措施: Placebo (Drug)
SAD: Cohort 4
Eight participants will be administered 170mg RO7020531 orally on Day 1.
干预措施: RO7020531 (Drug)
SAD: Cohort 2
Eight participants will be administered 100mg RO7020531 orally on Day 1.
干预措施: RO7020531 (Drug)
MAD: Cohort 1
Eight participants will be administered 100mg RO7020531 orally on Day 1 and every other day (QOD) for 14 days.
干预措施: RO7020531 (Drug)
SAD: Cohort 3
Eight participants will be administered 140mg RO7020531 orally on Day 1.
干预措施: RO7020531 (Drug)
SAD: Cohort 1
Eight participants will be administered 40mg RO7020531 orally on Day 1.
干预措施: RO7020531 (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events (AEs)
时间窗: Screening up until 28 days after the last dose of study drug (up to 1 year).
An Adverse Event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, any deterioration in a laboratory value or other clinical test or adverse events that are related to a protocol-mandated intervention, including those that occur prior to assignment of study treatment.
次要结局
- Renal Clearance of RO7020531, RO7011785, RO7018822 and RO7033805(SAD: Pre-dose, 0-4, 4-8, 8-12, 12-24h Day 1)
- Maximum Observed Plasma Concentration (Cmax) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)(SAD: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48 hours (h) Post-dose Days 1, 2; MAD: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24h Post-dose Days 1, 2 and Days 13, 14; Pre-dose, 2, 6, 24hr Post-dose Days 3, 5, 7, 9 and 11.)
- Half-Life (t1/2) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)(SAD: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48 hours (h) Post-dose Days 1, 2; MAD: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24h Post-dose Days 1, 2 and Days 13, 14; Pre-dose, 2, 6, 24hr Post-dose Days 3, 5, 7, 9 and 11.)
- Area Under the Plasma Concentration Versus Time Curve up to the Last Measurable Concentration (AUClast) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)(SAD: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48 hours (h) Post-dose Days 1, 2; MAD: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24h Post-dose Days 1, 2 and Days 13, 14; Pre-dose, 2, 6, 24hr Post-dose Days 3, 5, 7, 9 and 11.)
- Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)(SAD: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48 hours (h) Post-dose Days 1, 2; MAD: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24h Post-dose Days 1, 2 and Days 13, 14; Pre-dose, 2, 6, 24hr Post-dose Days 3, 5, 7, 9 and 11.)
- Total Amount Excreted as RO7020531, RO7011785, RO7018822 and RO7033805(SAD: Pre-dose, 0-4, 4-8, 8-12, 12-24h Day 1)
- Mean Fold Changes of Markers of Transcriptional Responses(SAD: Day -1, Pre-dose, 2, 6, 12, 24h Post-dose Day 1 to Day 2 and Day 8; MAD: Day -1, Pre-dose 2, 6, 12, 24h Post-dose Day 1 to Day 2, Pre-dose, 2, 6, 24h Post-dose Days 3, 5, 7, 13 and 20)
- Fraction Excreted as RO7020531, RO7011785, RO7018822 and RO7033805(SAD: Pre-dose, 0-4, 4-8, 8-12, 12-24h Day 1)
- Time to Maximum Observed Plasma Concentration (Tmax) for RO7020531, Main Active Metabolite (RO7011785) and Prodrug Metabolites (RO7018822 and RO7033805)(SAD: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48 hours (h) Post-dose Days 1, 2; MAD: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24h Post-dose Days 1, 2 and Days 13, 14; Pre-dose, 2, 6, 24hr Post-dose Days 3, 5, 7, 9 and 11.)
- Mean Concentrations of Protein and Metabolite Markers of Humoral Response(SAD: Day -1, Pre-dose, 2, 6, 12, 24h Post-dose Day 1 to Day 2, 3, 5, 8; MAD: Day -1, Pre-dose 2, 6, 12, 24h Post-dose Day 1 to Day 2, Pre-dose, 2, 6, 24h Post-dose Days 3, 5, 7, 13 and 20)
- Mean Fold Changes of Protein and Metabolite Markers of Humoral Response(SAD: Day -1, Pre-dose, 2, 6, 12, 24, 48 (only Neopterin), 96h (only Neopterin), Post-dose Day 1 to Day 2, 3, 5, 8; MAD: Day -1, Pre-dose 2, 6, 12, 24h Post-dose Day 1 to Day 2, Pre-dose, 2, 6, 24h Post-dose Days 3, 5, 7, 13 and 20)