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A Study of RO7830698 in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease

A Study of RO7830698 in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease

Recruiting
18-80 years
All
Phase 1/2

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Overview

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

Study details
    Chronic Obstructive Pulmonary Disease (COPD)
    Healthy Participants

NCT07822334

Hoffmann-La Roche

21 October 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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