A Study of RO7830698 in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
2026年9月11日 更新者:Hoffmann-La Roche
A Phase I, Randomized, Investigator and Participant-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of RO7830698 in Healthy Participants (Part 1) and in Participants With Chronic Obstructive Pulmonary Disease (Part 2)
This study will evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and pharmacodynamics (PD) of single and multiple doses of RO7830698 in healthy participants and participants with chronic obstructive pulmonary disease (COPD).
研究概览
研究类型
介入性
注册 (估计的)
104
阶段
- 阶段2
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
研究联系人备份
- 姓名:Reference Study ID Number: WP46321 https://forpatients.roche.com/ No attachments to email below.
- 电话号码:888-662-6728 (U.S. and Canada)
- 邮箱:global-roche-genentech-trials@gene.com
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
All participants:
- Body mass index (BMI) between 18 and 32 kilograms per meter square (kg/m2)
- Agreement to adhere to the contraception requirements
Part 1:
- Absence of evidence of any active or chronic disease
Part 2:
- Confirmed diagnosis of COPD for > 6 months, as defined by the Global Initiative for Chronic obstructive Lung Disease (GOLD) guidelines
- Using maintenance inhaled therapy that may include inhaled corticosteroids (ICS) and/or long-acting β-agonist (LABA) and/or long-acting muscarinic antagonist (LAMA) as separate inhaler(s) or in combination preparation(s)
- Current smoker or ex-smoker with a tobacco history of >= 10 pack years
Exclusion Criteria:
- Pregnant or breastfeeding, or planning to become pregnant during the study or within the timeframe in which contraception is required
- Current or chronic history of clinically significant liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert syndrome or asymptomatic gallstones) or cirrhosis
- Known history of allergy to drugs or other substances, or clinically significant, acute, and/or uncontrolled allergic disease
- Known or suspected history of immunosuppression
- History of recurrent severe infections and underlying conditions predisposing participant to infections
- History of disseminated herpes simplex infection, or recurrent (> 1 episode) or disseminated herpes zoster
- Autoimmune disease requiring systemic immunosuppressive therapy
- History of or presence of any clinically significant unstable cardiovascular disease
- Treatment with medications targeting the same pathways as RO7830698, immunomodulatory/ immunosuppressive therapy, or licensed biologics for COPD and asthma within protocol-defined periods
- Positive results for hepatitis B infection, human immunodeficiency virus infection, or hepatitis C infection at the Screening visit
- Evidence of tuberculosis infection or disease
- Participation in any clinical study of a drug or medical device within protocol-defined periods
- Any other conditions that may affect providing informed consent or study protocol adherence, or if study participation may affect study results or participant safety
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Part 1: Single Ascending Dose (SAD)
Healthy participants will receive single doses of RO7830698 or placebo.
|
参与者将根据方案中描述的时间表接受安慰剂。
其他名称:
Participants will receive RO7830698 as per the schedule described in the protocol.
|
|
实验性的:Part 2: Multiple Ascending Dose (MAD)
Participants with COPD will receive multiple doses of RO7830698 or placebo.
|
参与者将根据方案中描述的时间表接受安慰剂。
其他名称:
Participants will receive RO7830698 as per the schedule described in the protocol.
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Part 1: Incidence and Severity of Adverse Events (AEs)
大体时间:Up to approximately 50 weeks
|
Up to approximately 50 weeks
|
|
Part 2: Incidence and Severity of AEs
大体时间:Up to approximately 44 weeks
|
Up to approximately 44 weeks
|
|
Part 1: Incidence of Dose-limiting Adverse Events (DLAEs)
大体时间:Up to approximately 50 weeks
|
Up to approximately 50 weeks
|
|
Part 2: Incidence of DLAEs
大体时间:Up to approximately 44 weeks
|
Up to approximately 44 weeks
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Part 1 and Part 2: Plasma Concentration of RO7830698
大体时间:Part 1: Up to approximately 50; Part 2: Up to approximately 44 weeks
|
Part 1: Up to approximately 50; Part 2: Up to approximately 44 weeks
|
|
Part 1: Bioavailability (F) of RO7830698
大体时间:Up to approximately 50 weeks
|
Up to approximately 50 weeks
|
|
Part 1: Area Under the Concentration-Time Curve From Time 0 To Infinity (AUC inf) of RO7830698
大体时间:Up to approximately 50 weeks
|
Up to approximately 50 weeks
|
|
Part 1 and Part 2: Incidence of Anti-Drug Antibodies (ADAs) to RO7830698
大体时间:Part 1: Up to approximately 50; Part 2: Up to approximately 44 weeks
|
Part 1: Up to approximately 50; Part 2: Up to approximately 44 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任:Clinical Trials、Hoffmann-La Roche
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月20日
初级完成 (估计的)
2028年10月11日
研究完成 (估计的)
2029年6月20日
研究注册日期
首次提交
2026年9月11日
首先提交符合 QC 标准的
2026年9月11日
首次发布 (实际的)
2026年9月16日
研究记录更新
最后更新发布 (实际的)
2026年9月16日
上次提交的符合 QC 标准的更新
2026年9月11日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- WP46321
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.