A Phase I Study to Evaluate the Safety and Pharmacokinetics of RO7890597 Following Single and Multiple Ascending Doses, and the Effects of Food, Proton-Pump Inhibition, And CYP3A Inhibition in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Incidence and Severity of Adverse Events (AEs)
研究概览
简要总结
This study will evaluate the safety, pharmacokinetics (PK), and activity of single and multiple doses of RO7890597 compared with placebo in healthy volunteers. The study includes single ascending dose (SAD) stage, multiple ascending dose (MAD) stage, food-effect and proton pump inhibitor (PPI) stages, and a supplemental drug-drug interaction (DDI) stage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
SAD and MAD stages: Double Blind Food-effect, PPI, and DDI stages: Open-label
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Agreement to adhere to the contraception requirements.
- •Body mass index of 18 to 30 kilograms per square meter (kg/m²).
排除标准
- •Pregnant, breastfeeding, or intending to become pregnant during the study or required contraception period.
- •Treatment with investigational biologic therapy within 90 days or 5 elimination half-lives, whichever is longer, before study drug initiation.
- •Treatment with investigational non-biologic therapy within 28 days or 5 elimination half-lives, whichever is longer, before study drug initiation.
- •Treatment with immunosuppressive medication within 28 days or 5 elimination half-lives, whichever is longer, before study drug initiation.
- •Treatment with any vaccine within 14 days prior to initiation of study drug, or within 28 days for a live or live attenuated vaccine.
- •Poor peripheral venous access.
- •Major surgery within 28 days before study drug initiation or planned major surgery during the study.
- •Current infection or recent infection requiring antibiotics as defined in the protocol.
- •History of malignancy within 5 years before screening, except for specified adequately treated cancers.
- •History of clinically significant drug or food allergy.
研究组 & 干预措施
RO7890597
Participants will receive a single or multiple doses of RO7890597 alone, or with rabeprazole or itraconazole.
干预措施: RO7890597 (Drug)
Placebo
Participants will receive single or multiple doses of matching placebo.
干预措施: Placebo (Drug)
RO7890597
Participants will receive a single or multiple doses of RO7890597 alone, or with rabeprazole or itraconazole.
干预措施: Itraconazole (Drug)
RO7890597
Participants will receive a single or multiple doses of RO7890597 alone, or with rabeprazole or itraconazole.
干预措施: Rabeprazole (Drug)
结局指标
主要结局
Incidence and Severity of Adverse Events (AEs)
时间窗: Up to approximately 12 weeks
次要结局
- Plasma Concentration of RO7890597(At prespecified timepoints from baseline up to approximately 12 weeks)
- Plasma Concentration of RO7890597 Under Fasted and Fed Conditions(At prespecified timepoints from baseline up to approximately 12 weeks)
- Plasma Concentration of RO7890597 Alone and in Combination With Rabeprazole(At prespecified timepoints from baseline up to approximately 12 weeks)