[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651760":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":25,"responsibleParty":39,"collaborators":25,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":25,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":25,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":25,"overallStatus":61,"whyStopped":25,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":25},{"fullName":5,"class":6},"Insmed Incorporated","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1: Single Ascending Dose (SAD)","EXPERIMENTAL","Participants will receive single ascending dose (SAD) of INS1033 or a matching placebo orally under fasted conditions on Day 1.",[13,14],"Drug: INS1033","Drug: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Part 2: Multiple Ascending Dose (MAD)","Participants will receive multiple ascending dose (MAD) of INS1033 or a matching placebo orally under fasted conditions for up to 14 days.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","INS1033","Oral solution",[9,16],null,{"type":21,"name":27,"description":23,"armGroupLabels":28,"otherNames":25},"Placebo",[9,16],[30],{"name":31,"affiliation":5,"role":32},"Study Director","STUDY_DIRECTOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Insmed Medical Information","CONTACT","18444467633","medicalinformation@insmed.com",{"type":40,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100651760","phase-1-a-study-to-assess-the-safety-tolerability-and-pharmacokinetics-pk-of-ins1033-in-healthy-participants-100651760",false,"NCT07765706","A Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of INS1033 in Healthy Participants","A Phase 1, Randomized, Double-blind, Placebo-controlled, 2-Part Study to Assess Safety, Tolerability and Pharmacokinetics of Single and Multiple Oral Doses of INS1033 in Healthy Participants","Inclusion Criteria:\n\n* Healthy status as defined by the absence of evidence of any clinically significant, in the opinion of the Investigator, active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, serology, and urinalysis.\n* All values for hematology, coagulation and clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations, as judged by the Investigator. Clinical laboratory tests may be repeated once.\n\nExclusion Criteria:\n\n* Use of any investigational drug or device within 30 days of the first dose of INS1033, or within 5 half-lives, whichever is longer.\n* Any disease e.g. which, in the opinion of the Investigator, poses an unacceptable risk to the participants.\n* Clinically significant history of any drug sensitivity, drug allergy, or food allergy, as determined by the Investigator (such as anaphylaxis, hepatotoxicity, or treatment with steroids or epinephrine). Confirmatory circumstances would include treatment with epinephrine or in Emergency Department.\n\nNote: Other protocol-defined inclusion\u002Fexclusion criteria may apply.",true,"ALL","18 Years","50 Years",{"count":53,"type":54},116,"ESTIMATED","INTERVENTIONAL",[57],"PHASE1","The primary objective of this study is to assess the safety and tolerability of single and multiple ascending doses of INS1033 in healthy participants.",[60],"Healthy Volunteers","NOT_YET_RECRUITING","2026-08-10",{"date":64,"type":65},"2026-08-14","ACTUAL",{"date":67,"type":54},"2026-08-25",{"date":69,"type":54},"2027-03-22",{"name":5,"class":6}]