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临床试验/NCT07495813
NCT07495813进行中（未招募）1 期

A Phase I, Randomized, Double-Blind, Adaptive, Placebo-Controlled, Single- Ascending Dose and Multiple-Ascending Dose, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of RO7763505 Following Oral Administration in Healthy Participants and Patients With Stable Coronary Artery Disease

Hoffmann-La Roche2 个研究点 分布在 1 个国家目标入组 196 人开始时间: 2026年3月31日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
196
试验地点
2
主要终点
Part 1a and Part 1b: Percentage of Participants With Adverse Events (AEs)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study will evaluate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses (SAD) (Part 1a), multiple ascending doses (MAD) (Part 1b), and the food effect (Part 1c) of RO7763505 in healthy adult participant. In Part 2, the safety, tolerability, PK and PD of multiple doses of RO7763505 in participants with stable coronary artery diseases (CAD).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

Parts 1a, 1b, and 2: Double blind

Part 1c: Open-label

入排标准

年龄范围
18 Years 至 75 Years（Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

  • •Healthy biologically male and female participants of nonchildbearing potential or childbearing potential with no clinically relevant findings on physical examination at screening or baseline (assessed either on Day -2 or Day -1), including detailed medical and surgical history, vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, serology, and urinalysis
  • •No suspicion of cognitive impairment/dementia as judged by the Investigator
  • •Myocardial infarction before the screening visit
  • •Objective imaging evidence (coronary computed tomography [CT] angiography or invasive angiography) of coronary atherosclerosis Participants who underwent percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) are eligible if the procedure was done >6 months prior to screening
  • •A diagnosis of stable CAD, defined as being on stable guideline-directed medical therapy (GDMT) if tolerated for at least 90 days prior to screening with no planned changes or scheduled interventions during the study
  • •QTc of <= 450 milliseconds (ms) as determined by a single 12-lead ECG recording. If the initial ECG result of the triplicate is exclusionary, consecutive repeat ECG results must be within the acceptable limits. In participants with a stable bundle branch block where the QRS duration is > 120 ms, the QTcF will be calculated as: QTcF - (QRS - 100 ms)

排除标准

  • •Any condition or disease detected during the medical interview/physical examination that would render the participant unsuitable for the study, place the participant at undue risk, or interfere with the ability of the participant to complete the study in the opinion of the Investigator
  • •Vaccination within 28 days prior to Day 1 (non-live vaccines including influenza vaccination are permitted 14 days prior to Day 1) or planned before the end of the study. Investigators are advised to review the immunization status of participants who are considered for treatment with RO7763505 and follow local/national guidance for adult vaccination against infectious disease as they deem relevant
  • •Positive result on human immunodeficiency virus (HIV)-1 and HIV-2, hepatitis B virus (HBV) (either hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]), hepatitis C virus (HCV) antibody test, or tuberculosis (TB)
  • •Individuals with New York Heart Association (NYHA) Class III or IV heart failure
  • •Known or suspected immunocompromised state
  • •Treatment with any investigational therapy within 28 days or within five drug-elimination half-lives (whichever is longer; or longer than either if required by local regulations; if the half-life is unknown, the 90-day period applies) prior to Day 1, calculated from the day of the follow-up from the previous study

研究组 & 干预措施

Part 2: In Stable CAD Participants

Experimental

Participants with stable CAD will receive RO7763505 or matching placebo.

干预措施: Placebo (Drug)

Part 1: SAD, MAD, and Food Effect in Healthy Participants

Experimental

Healthy participants will receive RO7763505 or matching placebo.

干预措施: Placebo (Drug)

Part 1: SAD, MAD, and Food Effect in Healthy Participants

Experimental

Healthy participants will receive RO7763505 or matching placebo.

干预措施: RO7763505 (Drug)

Part 2: In Stable CAD Participants

Experimental

Participants with stable CAD will receive RO7763505 or matching placebo.

干预措施: RO7763505 (Drug)

结局指标

主要结局

Part 1a and Part 1b: Percentage of Participants With Adverse Events (AEs)

时间窗: Part 1a: Approximately up to 2 Weeks; Part 1b: Approximately up to 3 Weeks

Part 1c: Plasma Concentration of RO7763505 in Fasted and fed State

时间窗: Approximately up to 3 Weeks

Part 2: Percentage of Participants With AEs

时间窗: Approximately up to 6 Weeks

次要结局

  • Part 1a and Part 1b: Plasma Concentration of RO7763505 and its Metabolites(Part 1a: Approximately up to 2 Weeks; Part 1b: Approximately up to 3 Weeks)
  • Part 1a and Part 1b: Percentage Change From Baseline in Inhibition of Ex Vivo-Stimulated Interleukin-1 Beta ( IL-1β)(Part 1a: Baseline, Approximately up to 2 Weeks; Part 1b: Baseline, Approximately up to 3 Weeks)
  • Part 1c: Percentage of Participants With AEs(Approximately up to 3 Weeks)
  • Part 2: Plasma Concentration of RO7763505 and its Metabolites(Approximately up to 6 Weeks)
  • Part 2: Percentage Change From Baseline in Inhibition of Ex Vivo-Stimulated IL-1β(Baseline, Approximately up to 6 Weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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