Chronic Obstructive Pulmonary Disease (COPD)Phase 1/2NCT07822334
A Study of RO7830698 in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
A Phase 1/2 study testing RO7830698 in people with Chronic Obstructive Pulmonary Disease (COPD) and Healthy Participants, run by Hoffmann-La Roche at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Healthy Participants
- What is being tested?
- RO7830698
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Oct 2026to 20 Jun 2029
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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 join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: WP46321 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
United Kingdom1 site, 1 recruiting
- Recruiting
Medicines Evaluation Unit
Wythenshawe, Greater Manchester, M23 9QZ
About this study
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)
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).
- Being tested
- RO7830698, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7830698Drug
Participants will receive RO7830698 as per the schedule described in the protocol.
PlaceboDrug
Also called RO7275887
Participants will receive placebo as per the schedule described in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Single Ascending Dose (SAD) | Experimental | Healthy participants will receive single doses of RO7830698 or placebo. Receives: Drug: RO7830698; Drug: Placebo |
| Part 2: Multiple Ascending Dose (MAD) | Experimental | Participants with COPD will receive multiple doses of RO7830698 or placebo. Receives: Drug: RO7830698; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Incidence and Severity of Adverse Events (AEs)
Measured: Up to approximately 50 weeks
Part 2: Incidence and Severity of AEs
Measured: Up to approximately 44 weeks
Part 1: Incidence of Dose-limiting Adverse Events (DLAEs)
Measured: Up to approximately 50 weeks
Part 2: Incidence of DLAEs
Measured: Up to approximately 44 weeks
Secondary outcomes (4)
Part 1 and Part 2: Plasma Concentration of RO7830698
Measured: Part 1: Up to approximately 50; Part 2: Up to approximately 44 weeks
Part 1: Bioavailability (F) of RO7830698
Measured: Up to approximately 50 weeks
Part 1: Area Under the Concentration-Time Curve From Time 0 To Infinity (AUC inf) of RO7830698
Measured: Up to approximately 50 weeks
Part 1 and Part 2: Incidence of Anti-Drug Antibodies (ADAs) to RO7830698
Measured: Part 1: Up to approximately 50; Part 2: Up to approximately 44 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start20 Oct 2026 (estimated)
- Primary completion11 Oct 2028 (estimated)
- Study completion20 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822334
- Sponsor's protocol ID
- WP46321
- Status last verified
- Oct 2026
- First submitted
- 11 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No