Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07822334

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

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).

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

RO7830698

Drug

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

Placebo

Drug

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

Other names: RO7275887

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

Study contacts

Contact information is provided by the study sponsor or research team.

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Reference Study ID Number: WP46321 https://forpatients.roche.com/ No attachments to email below.

CONTACT

[email protected]

888-662-6728 (U.S. and Canada)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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)

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.