[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586201":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":51,"collaborators":24,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":24,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":24,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":24,"overallStatus":37,"whyStopped":24,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},{"fullName":5,"class":6},"Shanghai Huilun Pharmaceutical Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HL-1186","EXPERIMENTAL","Single dose ascending(SAD): participants will be randomized to receive a single dose of HL-1186 or placebo,dose ascending will be conducted sequentially from the low-dose cohort to the high-dose cohort Food effect(FE): participants will be randomized to group A or group B, to evaluate different fed conditions on the PK of HL-1186 Multiple ascending dose(MAD): participants will be randomized to receive Muliple doses of HL-1186 or placebo, dose ascending will be conducted sequentially from the low-dose cohort to the high-dose cohort",[13],"Drug: HL-1186",{"label":15,"type":16,"description":11,"interventionNames":17},"HL-1186 placebo","PLACEBO_COMPARATOR",[18],"Drug: HL-1186 placebo",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","HL-1186 tablet for oral administration.",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"HL-1186 placebo tablet for oral administration.",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Kangli Ma","CONTACT","021-64311017","clinical_trial@hllife.com.cn",[35],{"facility":36,"status":37,"city":38,"state":24,"zip":24,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Jiangnan University Affiliated Hospital","RECRUITING","Wuxi","China","CN",{"type":42,"coordinates":43},"Point",[44,45],120.28857,31.56887,{"lat":45,"lon":44},[48],{"name":36,"role":31,"phone":49,"phoneExt":24,"email":50},"13358100007","13358100007@126.com",{"type":52,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100586201","phase-1-assess-the-safety-tolerability-and-pharmacokinetics-of-hl-1186-in-healthy-participants-100586201",false,"NCT06912295","Assess the Safety, Tolerability, and Pharmacokinetics of HL-1186 in Healthy Participants","A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of HL-1186 in Healthy Participants","Inclusion Criteria:\n\n1. Healthy participants, males and females.\n2. Between the ages of 18 and 45 years old (inclusive).\n3. Weighs no less than 50 kg (for males) or 45 kg (for females) and body mass index (BMI) within 19.0 to 26.0 kg\u002Fm2 (inclusive).\n4. During the screening period, vital signs, physical examination, blood routine, blood biochemistry, coagulation function, urine routine, virology examination, chest X-ray, and pregnancy blood test (female) were examined, and the results did not show abnormalities or abnormalities without clinical significance.\n\nExclusion Criteria:\n\n1. Females who are pregnant or breastfeeding; females\u002Fmales who are prepared for having children.\n2. History or presence of neurological, cardiovascular, renal, hepatic, gastrointestinal, respiratory, hematological, endocrine, or osteoarticular disorders, or any laboratory abnormalities that pose a potential danger to constitute a risk when taking the study intervention or interfere with the interpretation of data.\n3. Active infectious diseases which need anti-infection treatment.\n4. Significant surgery within three months and not fully recovered per investigator's judgments.\n5. Significant allergies per investigator's judgments, e.g., food allergies, allergies, or atopic reactions to any components of the investigational drug or placebo, asthma attacks, etc.\n6. Immunosuppressive diseases, e.g., immunodeficiency, etc.",true,"ALL","18 Years","45 Years",{"count":65,"type":66},76,"ESTIMATED","INTERVENTIONAL",[69],"PHASE1","This single-center, randomized, double-blind, placebo-controlled, two-part study is designed to assess the safety, tolerability and PK of oral HL-1186 Tablet in healthy participants.",[72],"Healthy Participants","2025-08-19",{"date":75,"type":76},"2025-08-24","ACTUAL",{"date":78,"type":76},"2025-03-21",{"date":80,"type":66},"2025-10-09",{"name":82,"class":6},"Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.",1]