[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575943":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":37,"locations":43,"responsibleParty":62,"collaborators":32,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":32,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":32,"studyType":78,"phases":79,"briefSummary":82,"conditions":83,"keywords":32,"overallStatus":46,"whyStopped":32,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"MindRank AI Ltd","INDUSTRY",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"MDR-001（SAD）","EXPERIMENTAL","Single doses of MDR-001 administered orally.",[13],"Drug: MDR-001",{"label":15,"type":10,"description":16,"interventionNames":17},"Placebo (SAD)","Placebo administered orally.",[18],"Drug: palcebo",{"label":20,"type":10,"description":21,"interventionNames":22},"MDR-001 (MAD)","Multiple doses of MDR-001 administered orally.",[13],{"label":24,"type":10,"description":16,"interventionNames":25},"Placebo (MAD)",[18],[27,33],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","MDR-001","Oral administration of small molecule MDR-001 tablets",[20,9],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"palcebo","Administered orally placebo",[24,15],[38],{"name":39,"role":40,"phone":41,"phoneExt":32,"email":42},"Ruowen Guo","CONTACT","+86 0571-85233836","ruowen.guo@mindrank.cn",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":32,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"The first hospital of Jilin University","RECRUITING","Changchun","Jilin","China","CN",{"type":52,"coordinates":53},"Point",[54,55],125.32278,43.88,{"lat":55,"lon":54},[58,60],{"name":59,"role":40,"phone":32,"phoneExt":32,"email":32},"Yanhua Ding",{"name":61,"role":40,"phone":32,"phoneExt":32,"email":32},"Guixia Wang",{"type":63,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100575943","phase-1-a-phase-iiia-clinical-study-to-assess-the-single-and-multiple-ascending-doses-of-mdr-001-tablets-in-healthy-participants-and-obese-overweight-participants-100575943",false,"NCT06778850","A Phase I\u002FIIa Clinical Study to Assess the Single and Multiple Ascending Doses of MDR-001 Tablets in Healthy Participants and Obese\u002F Overweight Participants","A Randomized, Double-blind, Placebo-controlled Phase I\u002FIIa Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of MDR-001 Tablets Administrated Orally in Healthy Participants and Obese\u002F Overweight Participants","Inclusion Criteria:\n\n* Participants who are aged ≥ 18 and ≤ 55 years at the time of signing the informed consent; no gender restriction.\n* Participants with 27 ≤ body mass index (BMI) ≤ 45 kg\u002Fm2.\n* For male participants, a waist circumference ≥ 90 cm is required, while female participants ≥ 85 cm.\n\nExclusion Criteria:\n\n* Participants with any condition that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers.\n* Participants with personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia 2 (MEN2), or those with hereditary diseases that easily induce to medullary thyroid carcinoma.\n* Participants with a history of pancreatitis or symptomatic gallbladder disease.\n* Serum calcitonin \\> ULN at screening.\n* Participants with systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg at screening.\n* Participants with ALT \\>2 × ULN and \u002For AST \\> 2 × ULN at screening.\n* Participants whose fasting triglycerides \\> 5.7 mmol\u002FL, total cholesterol \\> 7.75 mmol\u002FL, low-density lipoprotein cholesterol \\> 4.9 mmol\u002FL at screening.\n* Participants with abnormal uric acid levels accompanied by clinical symptoms (those without clinical symptoms can be included).\n* Participants with fasting blood glucose levels \\> 7 mmol\u002FL.\n* Participants with creatinine clearance \\\u003C 60 mL\u002Fmin at screening \\[calculation formula: CLcr: (140 - age) × weight (kg) \u002F \\[72 × 0.0113 × Scr (μmol\u002FL)\\], × 0.85 for females\\].\n* Participants have experienced significant changes in diet or exercise habits or within ≥5% changes in body weight within 3 months prior to screening.\n* Participants with clinically significant ECG abnormality deemed unsuitable participation for study by the investigator; or with ECG QTcF values \\> 450 ms for male participants or \\> 470 ms for female participants.",true,"ALL","18 Years","55 Years",{"count":76,"type":77},131,"ESTIMATED","INTERVENTIONAL",[80,81],"PHASE1","PHASE2","To investigate the safety and tolerability after single and multiple ascending doses of MDR-001 Tablets administered orally in healthy participants and obese\u002F overweight participants.",[84],"Overweight and Obese Volunteers","2025-03-05",{"date":87,"type":88},"2025-03-07","ACTUAL",{"date":90,"type":88},"2023-06-09",{"date":92,"type":77},"2025-12-30",{"name":5,"class":6},1]