CClinicalTrials.gg
Not yet recruitingNCT07822334Updated Sep 16, 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. Not yet recruiting. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-16.

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

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

Who can participate

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

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

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
04

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

05

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

06

Study locations

No study locations are listed for this record.

07

References and documents

08

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
Sep 16, 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 ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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