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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Obstructive Pulmonary Disease (COPD); Healthy Participants
• Intervention / Treatment: Drug: Placebo; Drug: RO7830698

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
• Study Contact Backup: Name: Reference Study ID Number: WP46321 https://forpatients.roche.com/ No attachments to email below.; Phone Number: 888-662-6728 (U.S. and Canada); Email: global-roche-genentech-trials@gene.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Single Ascending Dose (SAD); Healthy participants will receive single doses of RO7830698 or placebo.	Drug: Placebo; Participants will receive placebo as per the schedule described in the protocol.; Other Names: RO7275887; Drug: RO7830698; Participants will receive RO7830698 as per the schedule described in the protocol.
Experimental: Part 2: Multiple Ascending Dose (MAD); Participants with COPD will receive multiple doses of RO7830698 or placebo.	Drug: Placebo; Participants will receive placebo as per the schedule described in the protocol.; Other Names: RO7275887; Drug: RO7830698; Participants will receive RO7830698 as per the schedule described in the protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Part 1: Incidence and Severity of Adverse Events (AEs)	Up to approximately 50 weeks
Part 2: Incidence and Severity of AEs	Up to approximately 44 weeks
Part 1: Incidence of Dose-limiting Adverse Events (DLAEs)	Up to approximately 50 weeks
Part 2: Incidence of DLAEs	Up to approximately 44 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Part 1 and Part 2: Plasma Concentration of RO7830698	Part 1: Up to approximately 50; Part 2: Up to approximately 44 weeks
Part 1: Bioavailability (F) of RO7830698	Up to approximately 50 weeks
Part 1: Area Under the Concentration-Time Curve From Time 0 To Infinity (AUC inf) of RO7830698	Up to approximately 50 weeks
Part 1 and Part 2: Incidence of Anti-Drug Antibodies (ADAs) to RO7830698	Part 1: Up to approximately 50; Part 2: Up to approximately 44 weeks

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Publications and helpful links

Helpful Links

• Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.

Study record dates

Study Major Dates

• Study Start (Estimated): October 20, 2026
• Primary Completion (Estimated): October 11, 2028
• Study Completion (Estimated): June 20, 2029

Study Registration Dates

• First Submitted: September 11, 2026
• First Submitted That Met QC Criteria: September 11, 2026
• First Posted (Actual): September 16, 2026

Study Record Updates

• Last Update Posted (Actual): September 16, 2026
• Last Update Submitted That Met QC Criteria: September 11, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: WP46321

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No