[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625048":3},{"organization":4,"armGroups":7,"interventions":32,"overallOfficials":38,"centralContacts":43,"locations":49,"responsibleParty":69,"collaborators":38,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":38,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":38,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":38,"overallStatus":52,"whyStopped":38,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Heronova Pharmaceuticals","INDUSTRY",[8,14,20,24,28],{"label":9,"type":10,"description":11,"interventionNames":12},"SAD: DC6001","EXPERIMENTAL","Participants received single dose of DC6001 orally. Dose levels are 2 mg, 5 mg, 10 mg, 20 mg and 40 mg.",[13],"Drug: DC6001",{"label":15,"type":16,"description":17,"interventionNames":18},"SAD: Placebo","PLACEBO_COMPARATOR","Participants received single dose of placebo orally.",[19],"Drug: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"MAD: DC6001","Participant received DC6001 orally once daily for 14 days. Dose levels are 2 mg, 5 mg and 10 mg.",[13],{"label":25,"type":16,"description":26,"interventionNames":27},"MAD: Placebo","Participant received DC6001 placebo matching DC6001 orally once daily for 14 days.",[19],{"label":29,"type":10,"description":30,"interventionNames":31},"FE: DC6001","Participants received single dose of DC6001 5 mg orally under fed conditions.",[13],[33,39],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"DRUG","DC6001","DC6001 tablet",[29,21,9],null,{"type":34,"name":40,"description":41,"armGroupLabels":42,"otherNames":38},"Placebo","DC6001 placebo tablet",[25,15],[44],{"name":45,"role":46,"phone":47,"phoneExt":38,"email":48},"Kang Ren","CONTACT","+86-13269683867","renkang@dcpc.com",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Beijing Tongren Hospital","RECRUITING","Beijing","Beijing Municipality","100730","China","CN",{"type":59,"coordinates":60},"Point",[61,62],116.39723,39.9075,{"lat":62,"lon":61},[65],{"name":66,"role":46,"phone":67,"phoneExt":38,"email":68},"Laichun Lu","+8613883933701","lulaicq@163.com",{"type":70,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100625048","phase-1-a-study-of-dc6001-tablet-in-healthy-chinese-adult-subjects-100625048",false,"NCT07417566","A Study of DC6001 Tablet in Healthy Chinese Adult Subjects","A Randomized, Double-Blind, Parallel Placebo-Controlled, Single and Multiple Ascending Dose Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Characteristics of Oral DC6001 Tablet in Healthy Chinese Adult Subjects","Inclusion Criteria:\n\n1. Healthy volunteers aged 18-55 years (inclusive) at the time of signing the informed consent form, regardless of gender;\n2. Male subjects with a body weight ≥ 50.0 kg and female subjects with a body weight ≥ 45.0 kg; BMI ranging from 19.0 to 28.0 kg\u002Fm² (inclusive of critical values);\n3. Women of childbearing potential (WOCBP) or male subjects must agree to have no childbearing plans and voluntarily adopt effective contraceptive measures for 6 months from pre-screening to the last administration of the study drug, with no plans for sperm or egg donation. For WOCBP: The serum pregnancy test result of WOCBP must be negative before the first administration;\n4. No history of major diseases; physical examination, vital signs, 12-lead electrocardiogram (ECG), chest X-ray, and laboratory test results during screening are normal, or slightly exceed the normal reference range but are deemed clinically insignificant by the investigator;\n5. Subjects are able to maintain good communication with the investigator, comply with all requirements of the clinical trial, and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n1. Subjects with clinically significant abnormalities or diseases occurring within 1 week prior to screening or currently present that require exclusion;\n2. Subjects with digestive system diseases affecting the absorption of fat-soluble vitamins occurring within 3 months prior to screening or currently present;\n3. Subjects with diseases related to vitamin A deficiency occurring within 3 months prior to screening or currently present;\n4. Subjects with acute diseases occurring from the screening phase to the first administration of the study drug that, in the investigator's judgment, may affect the study results;\n5. History of severe visual, ocular, or retinal diseases;\n6. Subjects with dysphagia;\n7. Subjects with known or suspected allergic reactions to the study drug or any of its excipients (as judged by the investigator); or subjects with clinically significant atopy or history of allergic diseases (as judged by the investigator);\n8. Subjects who have undergone surgery within 3 months prior to screening that, in the investigator's judgment, may affect drug absorption, distribution, metabolism, or excretion, or have severe surgical sequelae; or subjects planning to undergo surgery during the study;\n9. Subjects who have donated blood, lost a large amount of blood (≥ 400 mL), donated ≥ 2 units of component blood, or received blood transfusion within 3 months prior to the first administration of the study drug; or subjects planning to donate blood during the study;\n10. Subjects who have received any investigational drug or participated in any interventional clinical study within 3 months prior to the first administration of the study drug;\n11. Subjects who smoked an average of more than 5 cigarettes per day within 3 months prior to the first administration of the study drug, or cannot abstain from using any tobacco products during the study;\n12. Subjects who consumed an average of more than 14 units of alcohol per week within 3 months prior to the first administration of the study drug, or cannot abstain from using any alcohol-containing products during the study; or subjects with a positive breath alcohol test prior to study drug administration;\n13. Subjects who consumed excessive tea, coffee, and\u002For caffeinated beverages within 3 months prior to the first administration of the study drug, or cannot abstain from consuming tea, coffee, and\u002For caffeinated beverages during the study;\n14. Subjects who used any prescription drugs, over-the-counter drugs, Chinese patent medicines, Chinese herbal medicines, vitamins, or health food products within 28 days prior to screening or within 5 drug half-lives (whichever is shorter);\n15. Subjects whose 12-lead electrocardiogram (ECG) during the screening period meets any of the following criteria: 1) PR interval \\> 200 ms; 2) QTcF \\> 450 ms; 3) QRS duration \\> 110 ms; 4) QT interval \\> 500 ms; 5) Heart rate (HR) \\\u003C 50 bpm;\n16. Pregnant or lactating female subjects; or female subjects of childbearing potential (WOCBP) with a positive serum pregnancy test at any time prior to the first administration;\n17. Subjects with positive results or results exceeding the upper limit of the reference range in the eight infectious and immunological tests, which are deemed clinically significant by the investigator: hepatitis B virus (HBV) serology, hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV)-P24 antigen\u002Fantibody, and syphilis-specific antibody;\n18. Subjects with a positive urine drug screen or a history of drug abuse or drug use within 5 years prior to the study;\n19. Subjects who consumed or drank pitaya, mango, grapefruit, carambola, or foods\u002Fbeverages prepared from these fruits; or foods\u002Fbeverages containing xanthine, caffeine, or alcohol; or other special diets that may affect drug absorption, distribution, metabolism, or excretion within 72 hours prior to the first administration;\n20. Subjects with special dietary requirements, lactose intolerance, or inability to accept a unified diet;\n21. Subjects deemed unsuitable for participation in the study by the investigator.",true,"ALL","18 Years","55 Years",{"count":83,"type":84},76,"ESTIMATED","INTERVENTIONAL",[87],"PHASE1","This study adopts a randomized, double-blind, parallel placebo-controlled dose-escalation design, consisting of two parts: Part 1 includes a single ascending dose (SAD) study plus a food effect (FE) study, and Part 2 is a multiple ascending dose (MAD) study.",[90],"Stargardt Disease","2026-02-11",{"date":93,"type":94},"2026-02-18","ACTUAL",{"date":96,"type":94},"2026-01-01",{"date":98,"type":84},"2026-12-31",{"name":5,"class":6},1]