NCT07822334尚未招募1 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 104
- 主要终点
- Part 1: Incidence and Severity of Adverse Events (AEs)
研究概览
简要总结
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)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All participants:
- •Body mass index (BMI) between 18 and 32 kilograms per meter square (kg/m2)
- •Agreement to adhere to the contraception requirements
- •Absence of evidence of any active or chronic disease
- •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
排除标准
- •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
研究组 & 干预措施
Part 1: Single Ascending Dose (SAD)
Experimental
Healthy participants will receive single doses of RO7830698 or placebo.
干预措施: RO7830698 (Drug)
Part 1: Single Ascending Dose (SAD)
Experimental
Healthy participants will receive single doses of RO7830698 or placebo.
干预措施: Placebo (Drug)
Part 2: Multiple Ascending Dose (MAD)
Experimental
Participants with COPD will receive multiple doses of RO7830698 or placebo.
干预措施: RO7830698 (Drug)
Part 2: Multiple Ascending Dose (MAD)
Experimental
Participants with COPD will receive multiple doses of RO7830698 or placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Part 1: Incidence and Severity of Adverse Events (AEs)
时间窗: Up to approximately 50 weeks
Part 2: Incidence and Severity of AEs
时间窗: Up to approximately 44 weeks
Part 1: Incidence of Dose-limiting Adverse Events (DLAEs)
时间窗: Up to approximately 50 weeks
Part 2: Incidence of DLAEs
时间窗: Up to approximately 44 weeks
次要结局
- Part 1: Bioavailability (F) of RO7830698(Up to approximately 50 weeks)
- Part 1 and Part 2: Plasma Concentration of RO7830698(Part 1: Up to approximately 50; Part 2: Up to approximately 44 weeks)
- Part 1: Area Under the Concentration-Time Curve From Time 0 To Infinity (AUC inf) of RO7830698(Up to approximately 50 weeks)
- Part 1 and Part 2: Incidence of Anti-Drug Antibodies (ADAs) to RO7830698(Part 1: Up to approximately 50; Part 2: Up to approximately 44 weeks)
研究者
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