[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620533":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":11,"responsibleParty":29,"collaborators":11,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":11,"eligibilityCriteria":37,"healthyVolunteers":38,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":42,"targetDuration":11,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":11,"overallStatus":51,"whyStopped":11,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":11},{"fullName":5,"class":6},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"QLS1410 20mg","EXPERIMENTAL",null,[13],"Drug: QLS1410",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","QLS1410","QLS1410 tablets",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Yuguo Chen, B.M.","CONTACT","（+86）0531-82169023","chen919085@126.com",{"name":27,"role":23,"phone":24,"phoneExt":11,"email":28},"Wei Zhao, M.D.","zhao4wei2@hotmail.com",{"type":30,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100620533","phase-1-a-food-effect-study-of-qls1410-in-healthy-chinese-adults-100620533",false,"NCT07358858","A Food Effect Study of QLS1410 in Healthy Chinese Adults","A Randomized, Open-label, Two-period, Crossover Food Effect Study of QLS1410 in Healthy Chinese Adults","Inclusion Criteria:\n\n1. Able to understand and willing to comply with all study visits, procedures, restrictions and provide the written informed consent form (ICF).\n2. Males and females aged 18 to 55 years, inclusive.\n3. Weight ≥ 50 kg for males and ≥ 45 kg for females, Body mass index (BMI) between 18 and 26 kg\u002Fm\\^2, inclusive, at screening.\n4. Has a mean seated office systolic blood pressure (SBP) 110\\~139 mmHg (inclusive) and diastolic blood pressure (DBP) 70\\~89 mmHg (inclusive) at screening and baseline; measured 3 times consecutively (1-2 min intervals).\n5. QTcF (QT corrected using Fridericia's formula) \\\u003C450 ms for males and \\\u003C470 ms for females.\n6. Participants (including partners) must agree to abstain from sperm\u002Fegg donation and pregnancy plans, and to use highly effective contraception, from signing the ICF until 3 months after receiving the last dose of investigational product.\n\nExclusion Criteria:\n\n1. Any medical condition\u002Fdisease at screening deemed by the investigator to require exclusion, including but not limited to the cardiovascular, respiratory, digestive, urinary, endocrine metabolic, skeletal, muscular, hematologic, immune, nervous system.\n2. Dysphagia or any surgical condition\u002Fdisease that may affect drug absorption, distribution, metabolism, or excretion, at screening.\n3. Use of systemic corticosteroids within 3 months prior to screening.\n4. Any clinically significant abnormal result of vital signs, physical examinations, laboratory tests, chest X-ray, and abdominal B-ultrasound, at screening.\n5. Active viral hepatitis (B or C), TP, and HIV as demonstrated by positive serology at Screening.\n6. Mean pulse \\>100 or \\\u003C50 bpm after ≥5 min of rest at screening (measured 3 times consecutively).\n7. Any of the following laboratory abnormalities at screening: ALT or AST \\>1.5 x upper limit of normal (ULN); Total bilirubin \\>1.5 x ULN (participants with Gilbert's syndrome may qualify if direct bilirubin ≤ULN); Creatinine \\>ULN or eGFR \\\u003C90 mL\u002Fmin\u002F1.73 m²; Serum potassium \\>ULN or sodium \\\u003C135 mmol\u002FL.\n8. Smoking \\>5 cigarettes\u002Fday on average within 6 months before screening, or current use of e-cigarettes.\n9. Alcohol consumption \\>14 units\u002Fweek (1 unit = 357 mL of 3.5% beer, 27 mL of 40% spirits, or 104 mL of 12% wine) within 6 months before screening, or has a positive breath alcohol test at screening.\n10. Blood donation \\>400 mL within 3 months or \\>200 mL within 4 weeks before screening, or plan to donate blood during the study.\n11. Use of strong CYP3A4 or CYP1A2 inhibitors within 7 days or 5 half-lives (whichever is longer) before screening. Use of strong CYP3A4 inducer within 14 days or 5 half-lives (whichever is longer) before screening.\n12. Use of any prescription drugs, OTC drugs, traditional medicines, and dietary supplements within 2 weeks or 5 half-lives (whichever is longer) prior to randomization.\n13. Pregnant\u002Flactating females or positive pregnancy test at screening.\n14. Inability to tolerate a high-fat meal.",true,"ALL","18 Years","55 Years",{"count":43,"type":44},12,"ESTIMATED","INTERVENTIONAL",[47],"PHASE1","This study is aimed to evaluate the effect of food on pharmacokinetics of QLS1410 in healthy Chinese adults.",[50],"Uncontrolled Hypertension","NOT_YET_RECRUITING","2026-01-15",{"date":54,"type":55},"2026-01-22","ACTUAL",{"date":57,"type":44},"2026-01-23",{"date":59,"type":44},"2026-02-07",{"name":5,"class":6}]