NCT07822334RecruitingPhase 1/2
A Study of RO7830698 in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
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)
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 104 (estimated)
- First submitted
- 11 Sept 2026
- Start date
- Oct 2026
- Primary completion date
- Oct 2028
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- COPD
- NCT number
- NCT07822334
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 104
- From Oct 2026 to the primary completion date, Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with medications targeting the same pathways as RO7830698, immunomodulatory/ immunosuppressive therapy, or licensed biologics for COPD and asthma within protocol-defined periods
- Participation in any clinical study of a drug or medical device within protocol-defined periods
Other illness
- 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
- Positive results for hepatitis B infection, human immunodeficiency virus infection, or hepatitis C infection at the Screening visit
- Evidence of tuberculosis infection or disease
- Any other conditions that may affect providing informed consent or study protocol adherence, or if study participation may affect study results or participant safety
Other
- Pregnant or breastfeeding, or planning to become pregnant during the study or within the timeframe in which contraception is required
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medicines Evaluation Unit Coordinator of this site? Confirm its status | Wythenshawe | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.