[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634532":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":39,"centralContacts":42,"locations":47,"responsibleParty":73,"collaborators":34,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":34,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":34,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":96,"overallStatus":50,"whyStopped":34,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Enanta Pharmaceuticals, Inc","INDUSTRY",[8,14,18,24],{"label":9,"type":10,"description":11,"interventionNames":12},"EDP-978 SAD Cohorts","EXPERIMENTAL","EDP-978 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, Dose 6 and Dose 7, orally daily in one single administration",[13],"Drug: EDP-978",{"label":15,"type":10,"description":16,"interventionNames":17},"EDP-978 MAD Cohorts","EDP-978 Dose 1, Dose 2, Dose 3, Dose 4 and Dose 5 orally, once daily for 14 days",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"EDP-978 SAD Placebo Cohorts","PLACEBO_COMPARATOR","Matching placebo, orally, once daily in one single administration",[23],"Drug: Placebo",{"label":25,"type":20,"description":26,"interventionNames":27},"EDP-978 MAD Placebo Cohorts","Matching placebo, orally, once daily for 14 days",[23],[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","EDP-978","Oral administration",[15,9],null,{"type":30,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Placebo","Placebo to match EDP-978, oral administration",[25,19],[40],{"name":5,"affiliation":5,"role":41},"STUDY_DIRECTOR",[43],{"name":5,"role":44,"phone":45,"phoneExt":34,"email":46},"CONTACT","(617) 607-0800","emartin@enanta.com",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"ICON Early Phase","RECRUITING","San Antonio","Texas","78209","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-98.49363,29.42412,{"lat":60,"lon":59},[63,66,70],{"name":64,"role":44,"phone":34,"phoneExt":34,"email":65},"Shannon Kirk","Shannon.Kirk@iconplc.com",{"name":67,"role":44,"phone":68,"phoneExt":34,"email":69},"Shannon","9134102258","shannon.kirk@iconplc.com",{"name":71,"role":72,"phone":34,"phoneExt":34,"email":34},"Cassandra Key, MD","PRINCIPAL_INVESTIGATOR",{"type":74,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100634532","phase-1-a-study-to-investigate-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-single-and-multiple-doses-of-edp-978-in-healthy-adults-100634532",false,"NCT07540910","A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of EDP-978 in Healthy Adults","A Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, First-In-Human, Phase 1 Study of Orally Administered EDP-978 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses, Multiple Ascending Doses, and the Effect of Food on EDP-978 Pharmacokinetics in Healthy Adult Participants","Inclusion Criteria:\n\n* An informed consent document signed and dated by the subject.\n* Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive.\n\nExclusion Criteria:\n\n* Clinically relevant evidence or history of illness or disease.\n* Infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at screening and infection with SARS-CoV-2 at the Day -1 visit\n* Pregnant or nursing females.\n* History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.\n* A positive urine drug screen at screening or Day -1.\n* Current tobacco smokers or use of tobacco within 3 months prior to screening.\n* Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).\n* History of regular alcohol consumption.\n* Receipt of any vaccine, an investigational agent or biological product within 28 days or 5 times the t½, whichever one is longer, prior to first dose.",true,"ALL","18 Years","65 Years",{"count":87,"type":88},98,"ESTIMATED","INTERVENTIONAL",[91],"PHASE1","This study is a randomized, double-blind, sponsor-open, placebo-controlled study. 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