[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100358627":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":25,"locations":34,"responsibleParty":46,"collaborators":25,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":25,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":25,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":25,"overallStatus":69,"whyStopped":70,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Indalo Therapeutics, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"IDL-2965 Oral Capsule","EXPERIMENTAL","IDL-2965 oral capsule, single and multiple doses",[13],"Drug: IDL-2965 Oral Capsule",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Oral Capsule","PLACEBO_COMPARATOR","Placebo oral capsule, single and multiple doses",[19],"Drug: Placebos",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Investigational drug",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebos","Placebo",[15],[31],{"name":32,"affiliation":5,"role":33},"Jim Bush, MRCS FFPM","STUDY_DIRECTOR",[35],{"facility":36,"status":25,"city":37,"state":25,"zip":25,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":25},"Covance CRU","Leeds","United Kingdom","UK",{"type":41,"coordinates":42},"Point",[43,44],-1.54785,53.79648,{"lat":44,"lon":43},{"type":47,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100358627","phase-1-a-study-of-safety--blood-levels-of-idl-2965-in-healthy-subjects-and-patients-with-a-special-type-of-pulmonary-fibrosis-100358627",false,"NCT03949530","A Study of Safety & Blood Levels of IDL-2965 in Healthy Subjects and Patients With a Special Type of Pulmonary Fibrosis","IDL-2965 - A Phase I, Randomized, Double-blind, Placebo-controlled, Single and Multiple Oral Dose, Safety, Tolerability, and Pharmacokinetic Study in Healthy Subjects and Subjects With Idiopathic Pulmonary Fibrosis (IPF)","Inclusion Criteria:\n\nHealthy subjects:\n\n• Male and female subjects aged between 18 and 60 years, with a body mass index between 18.0 and 32.0 kg\u002Fm2.\n\nIPF subjects:\n\n* Male and female subjects over 40 years of age.\n* Diagnosis of idiopathic pulmonary fibrosis\n* Idiopathic pulmonary fibrosis has been stable for at least 3 months.\n\nExclusion Criteria:\n\nHealthy subjects and IPF subjects:\n\n* Significant history or clinical manifestation of any disease\u002Fdisorder, other than IPF.\n* History of significant hypersensitivity, intolerance, or allergy to any drug compound\n* Poor peripheral venous access\n* Use or intend to use any medications, tobacco or nicotine containing products or electronic cigarettes.\n* History of stomach or intestinal surgery or resection that would potentially alter absorption and\u002For excretion of orally administered drugs\n\nIPF subjects:\n\n• Pulmonary function tests and other diagnostic procedures inconsistent with diagnosis of idiopathic pulmonary fibrosis.",true,"ALL","18 Years","60 Years",{"count":60,"type":61},6,"ACTUAL","INTERVENTIONAL",[64],"PHASE1","The purpose of this study is to test the safety and tolerability of the drug candidate IDL-2965 and to see how it is absorbed, processed, and removed by the body.",[67,68],"Healthy Volunteers","Idiopathic Pulmonary Fibrosis","TERMINATED","Due to development challenges associated with the SARS-CoV-2 pandemic and emerging nonclinical data","2020-07-31",{"date":73,"type":61},"2020-08-04",{"date":75,"type":61},"2019-04-16",{"date":77,"type":61},"2020-03-29",{"name":5,"class":6},1]