[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656261":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":11,"studyPopulation":11,"armGroups":40,"interventions":52,"overallOfficials":64,"centralContacts":68,"locations":11,"responsibleParty":76,"collaborators":11,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":11,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":11,"studyType":92,"phases":93,"briefSummary":96,"conditions":97,"keywords":11,"overallStatus":100,"whyStopped":11,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":11},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":11},[9,13,16,18],{"measure":10,"description":11,"timeFrame":12},"Part 1: Incidence and Severity of Adverse Events (AEs)",null,"Up to approximately 50 weeks",{"measure":14,"description":11,"timeFrame":15},"Part 2: Incidence and Severity of AEs","Up to approximately 44 weeks",{"measure":17,"description":11,"timeFrame":12},"Part 1: Incidence of Dose-limiting Adverse Events (DLAEs)",{"measure":19,"description":11,"timeFrame":15},"Part 2: Incidence of DLAEs",[21,24,26,28],{"measure":22,"description":11,"timeFrame":23},"Part 1 and Part 2: Plasma Concentration of RO7830698","Part 1: Up to approximately 50; Part 2: Up to approximately 44 weeks",{"measure":25,"description":11,"timeFrame":12},"Part 1: Bioavailability (F) of RO7830698",{"measure":27,"description":11,"timeFrame":12},"Part 1: Area Under the Concentration-Time Curve From Time 0 To Infinity (AUC inf) of RO7830698",{"measure":29,"description":11,"timeFrame":23},"Part 1 and Part 2: Incidence of Anti-Drug Antibodies (ADAs) to RO7830698",{"allocation":31,"interventionModel":32,"interventionModelDescription":11,"primaryPurpose":33,"observationalModel":11,"timePerspective":11,"maskingInfo":34},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":35,"maskingDescription":11,"whoMasked":36},"TRIPLE",[37,38,39],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR",[41,48],{"label":42,"type":43,"description":44,"interventionNames":45},"Part 1: Single Ascending Dose (SAD)","EXPERIMENTAL","Healthy participants will receive single doses of RO7830698 or placebo.",[46,47],"Drug: RO7830698","Drug: Placebo",{"label":49,"type":43,"description":50,"interventionNames":51},"Part 2: Multiple Ascending Dose (MAD)","Participants with COPD will receive multiple doses of RO7830698 or placebo.",[46,47],[53,58],{"type":54,"name":55,"description":56,"armGroupLabels":57,"otherNames":11},"DRUG","RO7830698","Participants will receive RO7830698 as per the schedule described in the protocol.",[42,49],{"type":54,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"Placebo","Participants will receive placebo as per the schedule described in the protocol.",[42,49],[63],"RO7275887",[65],{"name":66,"affiliation":5,"role":67},"Clinical Trials","STUDY_DIRECTOR",[69,74],{"name":70,"role":71,"phone":72,"phoneExt":11,"email":73},"Reference Study ID Number: WP46321 https:\u002F\u002Fforpatients.roche.com\u002F No attachments to email below.","CONTACT","888-662-6728 (U.S. and Canada)","global-roche-genentech-trials@gene.com",{"name":75,"role":71,"phone":11,"phoneExt":11,"email":11},"Fastest response: use the inquiry form. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",{"type":77,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100656261","phase-1-a-study-of-ro7830698-in-healthy-participants-and-participants-with-chronic-obstructive-pulmonary-disease-100656261",false,"NCT07822334","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)","Inclusion Criteria:\n\nAll participants:\n\n* Body mass index (BMI) between 18 and 32 kilograms per meter square (kg\u002Fm2)\n* Agreement to adhere to the contraception requirements\n\nPart 1:\n\n* Absence of evidence of any active or chronic disease\n\nPart 2:\n\n* Confirmed diagnosis of COPD for \\> 6 months, as defined by the Global Initiative for Chronic obstructive Lung Disease (GOLD) guidelines\n* Using maintenance inhaled therapy that may include inhaled corticosteroids (ICS) and\u002For long-acting β-agonist (LABA) and\u002For long-acting muscarinic antagonist (LAMA) as separate inhaler(s) or in combination preparation(s)\n* Current smoker or ex-smoker with a tobacco history of \\>= 10 pack years\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding, or planning to become pregnant during the study or within the timeframe in which contraception is required\n* 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\n* Known history of allergy to drugs or other substances, or clinically significant, acute, and\u002For uncontrolled allergic disease\n* Known or suspected history of immunosuppression\n* History of recurrent severe infections and underlying conditions predisposing participant to infections\n* History of disseminated herpes simplex infection, or recurrent (\\> 1 episode) or disseminated herpes zoster\n* Autoimmune disease requiring systemic immunosuppressive therapy\n* History of or presence of any clinically significant unstable cardiovascular disease\n* Treatment with medications targeting the same pathways as RO7830698, immunomodulatory\u002F immunosuppressive therapy, or licensed biologics for COPD and asthma within protocol-defined periods\n* Positive results for hepatitis B infection, human immunodeficiency virus infection, or hepatitis C infection at the Screening visit\n* Evidence of tuberculosis infection or disease\n* Participation in any clinical study of a drug or medical device within protocol-defined periods\n* Any other conditions that may affect providing informed consent or study protocol adherence, or if study participation may affect study results or participant safety",true,"ALL","18 Years","80 Years",{"count":90,"type":91},104,"ESTIMATED","INTERVENTIONAL",[94,95],"PHASE1","PHASE2","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).",[98,99],"Chronic Obstructive Pulmonary Disease (COPD)","Healthy Participants","NOT_YET_RECRUITING","2026-09-11",{"date":103,"type":104},"2026-09-16","ACTUAL",{"date":106,"type":91},"2026-10-20",{"date":108,"type":91},"2029-06-20",{"name":5,"class":6}]