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临床试验 NCT07495813 针对Stable Coronary Artery Disease，健康志愿者目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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罗氏A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease I期 196
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临床试验NCT07495813旨在研究治疗，主要针对Stable Coronary Artery Disease，健康志愿者。这是一项I期 干预性研究试验，目前试验状态为招募中。试验始于2026年3月31日，计划招募196名患者。该研究由罗氏主导，预计于2027年12月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月27日。
简要概括
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).
官方标题
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
疾病
Stable Coronary Artery Disease健康志愿者其他研究标识符
- BP46355
- 2025-524693-42-00 (欧盟试验 (CTIS) 编号)
NCT编号
实际开始日期
2026-03-31
最近更新发布
2026-03-27
预计完成日期
2027-12-31
计划入组人数
196
研究类型
干预性研究
试验分期 (阶段)
I期
试验状态
招募中
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
三盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Part 1: SAD, MAD, and Food Effect in Healthy Participants Healthy participants will receive RO7763505 or matching placebo. | RO7763505 Participants will receive RO7763505 as per the schedule described in the protocol. 安慰剂 Participants will receive matching placebo as per the schedule described in the protocol. |
实验性Part 2: In Stable CAD Participants Participants with stable CAD will receive RO7763505 or matching placebo. | RO7763505 Participants will receive RO7763505 as per the schedule described in the protocol. 安慰剂 Participants will receive matching placebo as per the schedule described in the protocol. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Part 1a and Part 1b: Percentage of Participants With Adverse Events (AEs) | 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 | Approximately up to 3 Weeks | |
Part 2: Percentage of Participants With AEs | Approximately up to 6 Weeks |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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 |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
接受健康志愿者
是
Part 1:
- 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
Part 2:
- 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)
Part 1:
- 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)
Part 2:
- 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
罗氏研究中心联系人
联系人: Reference Study ID Number: BP46355 https://forpatients.roche.com/, 888-662-6728 (U.S. and Canada), [email protected]
1 位于 1 个国家/地区的研究中心
ICON Plc (LPRA) - Netherlands, Groningen, 9728 NZ, Netherlands
招募中