[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100440795":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":23,"centralContacts":23,"locations":26,"responsibleParty":40,"collaborators":23,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":23,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":23,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":23,"overallStatus":62,"whyStopped":23,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},{"fullName":5,"class":6},"NImmune Biopharma","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"NIM-1324","EXPERIMENTAL","Once daily oral tablet",[13],"Drug: NIM-1324",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,24],{"type":21,"name":9,"description":11,"armGroupLabels":22,"otherNames":23},"DRUG",[9],null,{"type":21,"name":15,"description":11,"armGroupLabels":25,"otherNames":23},[15],[27],{"facility":28,"status":23,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":23},"Clinical Site","Herston","Queensland","4006","Australia","AU",{"type":35,"coordinates":36},"Point",[37,38],153.01852,-27.44453,{"lat":38,"lon":37},{"type":41,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100440795","phase-1-safety-tolerability-and-pharmacokinetics-of-oral-nim-1324-in-healthy-adult-male-and-female-volunteers-100440795",false,"NCT05019950","Safety Tolerability and Pharmacokinetics of Oral NIM-1324 in Healthy Adult Male and Female Volunteers","A Randomized, Placebo-Controlled, Double-Blind, Single-Center Study to Evaluate Safety Tolerability and Pharmacokinetics of Oral NIM-1324 in Healthy Adult Male and Female Volunteers","Key Inclusion Criteria:\n\n1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects;\n2. Adult males and females, 18 to 64 years of age (inclusive) at screening;\n3. Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.\n\nKey Exclusion Criteria:\n\n1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or surgery within the past 3 months determined by the PI to be clinically relevant;\n2. Current infection that requires antibiotic, antifungal, antiparasitic or antiviral medications;\n3. COVID-19: Testing positive for COVID-19, a current symptomatic infection within 20 days, or an asymptomatic infection within 6 weeks.",true,"ALL","18 Years","64 Years",{"count":54,"type":55},56,"ACTUAL","INTERVENTIONAL",[58],"PHASE1","This is a randomized, double-blind, placebo-controlled, ascending dose, multi-cohort study. The primary objective of this study is to assess the safety and tolerability of single and 7-day repeat oral doses NIM-1324 in healthy adult volunteers.",[61],"Normal Healthy Volunteers","COMPLETED","2023-06-06",{"date":65,"type":55},"2023-06-08",{"date":67,"type":55},"2021-10-28",{"date":69,"type":55},"2022-04-28",{"name":5,"class":6},1]