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

NCT07822334 | Not Yet Recruiting Phase 1

• 1 other identifier: WP46321
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Healthy Participants; Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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

Study Arms (2)

Part 1: Single Ascending Dose (SAD)

EXPERIMENTAL

Healthy participants will receive single doses of RO7830698 or placebo.

Drug: RO7830698; Drug: Placebo

Part 2: Multiple Ascending Dose (MAD)

EXPERIMENTAL

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

Drug: RO7830698; Drug: Placebo

Interventions

RO7830698 DRUG

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

Part 1: Single Ascending Dose (SAD); Part 2: Multiple Ascending Dose (MAD)

Placebo DRUG

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

Also known as: RO7275887

Part 1: Single Ascending Dose (SAD); Part 2: Multiple Ascending Dose (MAD)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Related 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

888-662-6728 (U.S. and Canada); global-roche-genentech-trials@gene.com

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

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2026
• First Posted: September 16, 2026
• Study Start (Estimated): October 20, 2026
• Primary Completion (Estimated): October 11, 2028
• Study Completion (Estimated): June 20, 2029
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share