Chronic Obstructive Pulmonary Disease (COPD), Healthy Participants
Conditions
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).
Interventions
DRUGRO7830698
Participants will receive RO7830698 as per the schedule described in the protocol.
DRUGPlacebo
Participants will receive placebo as per the schedule described in the protocol.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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
| 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 |
Contacts
CONTACTReference Study ID Number: WP46321 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed