Recruiting
Phase 1/2
A Study of RO7830698 in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Condition(s) studied
Chronic Obstructive Pulmonary Disease (COPD)Healthy Participants
Investigational drug(s) / intervention(s)
RO7830698Placebo
RO7830698: Participants will receive RO7830698 as per the schedule described in the protocol.
Placebo: Participants will receive placebo as per the schedule described in the protocol.
Study summary
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).
Eligibility
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
Primary outcome measure(s)
- Part 1: Incidence and Severity of Adverse Events (AEs) — Up to approximately 50 weeks
- Part 2: Incidence and Severity of AEs — Up to approximately 44 weeks
- Part 1: Incidence of Dose-limiting Adverse Events (DLAEs) — Up to approximately 50 weeks
- Part 2: Incidence of DLAEs — Up to approximately 44 weeks
Trial sites (1)
| Facility | City | Region | Status |
| Medicines Evaluation Unit |
Wythenshawe |
Greater Manchester |
Recruiting |
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