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RecruitingNCT07822334Updated Oct 20, 2026

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

A Phase 1/2 interventional study of RO7830698 and Placebo in Chronic Obstructive Pulmonary Disease (COPD) and Healthy Participants, sponsored by Hoffmann-La Roche. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Hoffmann-La Roche · Phase 1/2, Interventional, and Treatment

Updated Oct 20, 2026Now RecruitingFirst site in United Kingdom+1 moreGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

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).

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease (COPD)
  • Healthy Participants
03

In context

Pulmonary Disease, Chronic Obstructive

5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.

This study's planned enrollment of 104 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.

Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

All participants:

  • (BMI) between 18 and 32 kilograms per meter square (kg/m2)
  • Agreement to adhere to the requirements

Part 1:

  • Absence of evidence of any active or chronic disease

Part 2:

  • Confirmed diagnosis of for > 6 months, as defined by the Global Initiative for Chronic obstructive Lung Disease (GOLD) guidelines
  • Using maintenance inhaled therapy that may include inhaled (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

Exclusion Criteria:

  • Pregnant or breastfeeding, or planning to become pregnant during the study or within the timeframe in which is required
  • Current or chronic history of 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
  • 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
  • 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 and asthma within protocol-defined periods
  • Positive results for infection, infection, or 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 or study protocol adherence, or if study participation may affect study results or participant safety
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
104 participants (estimated)

Study arms

  • Experimental
    Part 1: Single Ascending Dose (SAD)

    Healthy participants will receive single doses of RO7830698 or placebo.

    Drug: RO7830698 · Drug: Placebo

  • Experimental
    Part 2: Multiple Ascending Dose (MAD)

    Participants with COPD will receive multiple doses of RO7830698 or placebo.

    Drug: RO7830698 · Drug: Placebo

Interventions

  • DrugRO7830698

    Participants will receive RO7830698 as per the schedule described in the protocol.

  • DrugPlacebo

    Participants will receive placebo as per the schedule described in the protocol.

    Also known as: RO7275887

06

What researchers measure

Primary outcomes

  1. Part 1: Incidence and Severity of Adverse Events (AEs)

    Time frame: Up to approximately 50 weeks

  2. Part 2: Incidence and Severity of AEs

    Time frame: Up to approximately 44 weeks

  3. Part 1: Incidence of Dose-limiting Adverse Events (DLAEs)

    Time frame: Up to approximately 50 weeks

  4. Part 2: Incidence of DLAEs

    Time frame: Up to approximately 44 weeks

Secondary outcomes

  1. Part 1 and Part 2: Plasma Concentration of RO7830698

    Time frame: Part 1: Up to approximately 50; Part 2: Up to approximately 44 weeks

  2. Part 1: Bioavailability (F) of RO7830698

    Time frame: Up to approximately 50 weeks

  3. Part 1: Area Under the Concentration-Time Curve From Time 0 To Infinity (AUC inf) of RO7830698

    Time frame: Up to approximately 50 weeks

  4. Part 1 and Part 2: Incidence of Anti-Drug Antibodies (ADAs) to RO7830698

    Time frame: Part 1: Up to approximately 50; Part 2: Up to approximately 44 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

09

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 20, 2026
Sites
1 site added — first site in United Kingdom
Show site
  • Medicines Evaluation Unit · Wythenshawe, United Kingdom
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in United Kingdom
    Show site
    • Medicines Evaluation Unit · Wythenshawe, United Kingdom
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07822334
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Sep 16, 2026
Start date
Oct 20, 2026 (estimated)
Primary completion
Oct 11, 2028 (estimated)
Completion
Jun 20, 2029 (estimated)
Last update
Oct 20, 2026

Study contacts

Reference Study ID Number: WP46321 https://forpatients.roche.com/ No attachments to email below.
Contact
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Contact
Clinical Trials
study director · Hoffmann-La Roche

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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