Taking people in United KingdomPhase 1/2
Testing RO7830698 in Healthy Adults and Adults With Chronic Obstructive Pulmonary Disease
Tests how safe RO7830698 is in healthy adults and adults with COPD.
Key facts
- Who runs it
- Hoffmann-La Roche
- Where
- Wythenshawe, United KingdomSee the site
- Trial code
- Registry title
- A Study of RO7830698 in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 104 people, planned
- Started
- 28 Oct 2026
- Expected to end
- 20 Jun 2029
- Type of study
- Interventional, 2 groups
- Treatments tested
- RO7830698
- Placebo
- Record updated
- 13 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for healthy adults (Part 1) and adults with COPD (Part 2) to test the safety and effects of RO7830698.
- Age
- 18 to 80 years.
- Sex
- All sexes can join.
- Disease stage
- Part 1: healthy, with no active or chronic disease. Part 2: COPD diagnosed for more than 6 months, based on GOLD guidelines.
- Earlier treatment
- Part 2: must use maintenance inhaled therapy (inhaled corticosteroids and/or long-acting β-agonist and/or long-acting muscarinic antagonist). Cannot have had medicines for the same pathways as RO7830698, immune-suppressing treatment, or licensed biologics for COPD and asthma within protocol-defined periods.
- Biomarker or test result
- Part 2: current smoker or ex-smoker with a tobacco history of >= 10 pack years. All: body mass index (BMI) between 18 and 32 kg/m2.
Main reasons for not taking part
- Pregnant or breastfeeding, or planning pregnancy during the study
- Liver disease or known liver or bile abnormalities (except Gilbert syndrome or silent gallstones)
- Known or suspected weak immune system, or autoimmune disease needing immune-suppressing treatment
- Positive test for hepatitis B, hepatitis C or HIV, or signs of tuberculosis
- Unstable heart or blood vessel disease
The registry criteria, word for word
Show all 20 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- Pregnant or breastfeeding, or planning to become pregnant during the study or within the timeframe in which contraception is required
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in United Kingdom
- Medicines Evaluation UnitWythenshawe, United KingdomTaking people
About the trial
What the trial wants to find out
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).
The 2 groups in the trial
- Part 1: Single Ascending Dose (SAD)Treatment being tested
Healthy participants will receive single doses of RO7830698 or placebo.
Treatment: RO7830698 and Placebo
- Part 2: Multiple Ascending Dose (MAD)Treatment being tested
Participants with COPD will receive multiple doses of RO7830698 or placebo.
Treatment: RO7830698 and Placebo
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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)
- Plain-language title
- Testing RO7830698 in Healthy Adults and Adults With Chronic Obstructive Pulmonary DiseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Fit questions
- Built from NCT07822334, who can take part
- Record updated
- 13 November 2026