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

NCT07822334 — Phase 1 / Phase 2, Recruiting, 104 participants, Hoffmann-La Roche

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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)

RegistryNCT07822334
StatusRecruiting
PhasePhase 1 / Phase 2
Study typeInterventional; randomized, parallel, masking: triple, treatment
Enrollment104 (Estimated)
SponsorHoffmann-La Roche (Industry)
ConditionsChronic Obstructive Pulmonary Disease (COPD), Healthy Participants
InterventionsRO7830698, Placebo (Drug)
Datesstart 2026-10-20 (estimated), primary completion 2028-10-11 (estimated), completion 2029-06-20 (estimated), first posted 2026-09-16, last updated 2026-10-20
Locations1 site in United Kingdom

Related Papers Related Patents Related Grants Related Experts
All trials for Chronic Obstructive Pulmonary Disease (COPD) All trials for Healthy Participants All trials of RO7830698 All trials of Placebo

-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).

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+Arms and interventions

ArmTypeInterventionsDescription
Part 1: Single Ascending Dose (SAD)ExperimentalDrug: RO7830698; Drug: PlaceboHealthy participants will receive single doses of RO7830698 or placebo.
Part 2: Multiple Ascending Dose (MAD)ExperimentalDrug: RO7830698; Drug: PlaceboParticipants with COPD will receive multiple doses of RO7830698 or placebo.
  • RO7830698 (Drug): Participants will receive RO7830698 as per the schedule described in the protocol.
  • Placebo (Drug), also known as RO7275887: Participants will receive placebo as per the schedule described in the protocol.

+Outcome measures

Primary outcomes

  • 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

  • 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]

+Eligibility

Sex: All, ages: 18 Years to 80 Years, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
Medicines Evaluation UnitWythenshawe, Greater ManchesterUnited KingdomRecruiting

+Investigators

  • Clinical Trials, Study director, Hoffmann-La Roche