RO7830698 in healthy people and COPD patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1/2 interventional study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of single and multiple doses of RO7830698 compared with placebo. Participants include healthy volunteers and adults with COPD who are current or former smokers. The trial uses a controlled dosing approach across two parts to explore dosing and initial clinical signals. Criteria cover BMI range, contraception, and, for the COPD group, confirmed disease with maintenance inhaled therapy. The study is led by Hoffmann-La Roche and conducted at the Medicines Evaluation Unit in Greater Manchester.

Why it matters

Who can join: the full rules

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

Where it's running

• Medicines Evaluation Unit
  Wythenshawe, Greater Manchester, United Kingdom Recruiting

Study contacts

• Study coordinator: Reference Study ID Number: WP46321 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. and Canada)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.