[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cadmium-exceeds-the-standard\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cadmium-exceeds-the-standard":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100597355","phase-2-the-safety-and-efficacy-of-gmdtc-for-injection-in-subjects-with-elevated-cadmium-levels-100597355",false,"NCT07057414","The Safety and Efficacy of GMDTC for Injection in Subjects With Elevated Cadmium Levels","Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Single-Center Clinical Study to Evaluate the Safety and Efficacy of GMDTC for Injection in Subjects With Elevated Cadmium Levels","Inclusion Criteria:\n\nStudy participants must meet all of the following criteria to be enrolled in this trial:\n\n1. Voluntarily sign the informed consent form, aged between 18 and 70 years (inclusive), regardless of gender;\n2. Single morning urine cadmium \\>5 μg\u002Fg creatinine (with creatinine concentration ≥0.3 g\u002FL and ≤3 g\u002FL);\n3. eGFR ≥30 mL\u002Fmin\u002F1.73 m² (calculated using the CKD-EPI formula).\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will be excluded from this study:\n\n1. Currently suffering from any clinically significant disease that, in the investigator's judgment, poses a safety risk for participation in this clinical trial;\n2. Patients with a history of kidney disease requiring hemodialysis;\n3. Patients with a history of severe infusion-related allergic reactions, known allergies to three or more substances, or known hypersensitivity to any component of this product (e.g., disodium edetate, mannitol);\n4. Previous diagnosis of diabetes with poorly controlled blood glucose;\n5. History of conditions predisposing to hypokalemia (e.g., periodic hypokalemia, primary aldosteronism);\n6. High-risk uncontrolled arrhythmia within the past 6 months, including:\n\n1\\) Resting atrial tachycardia with heart rate \\>100 bpm, 2) Significant ventricular arrhythmia (e.g., ventricular tachycardia), 3) High-grade atrioventricular block (e.g., Mobitz type II second-degree or third-degree AV block), 4) NYHA Class IV heart failure, 5) Left ventricular ejection fraction (LVEF) \\\u003C50%; 7.Prolonged QT\u002FQTc interval at screening\u002Fbaseline (QTc: \\>450 ms in males, \\>470 ms in females) or known family history of long QT syndrome; 8. Use of any medication or supplement (e.g., SGLT2 inhibitors like dapagliflozin, canagliflozin, empagliflozin, etc.; GLUT2 inhibitors like cytochalasin B, phloretin, etc.) within 14 days prior to screening that may interact with the investigational drug; 9. Participation in any other clinical trial involving investigational drugs or medical devices within 3 months prior to screening; 10. Major surgery within 4 weeks before screening or planned surgery during the trial that may affect drug metabolism or safety assessment; 11. Blood donation or significant blood loss (≥200 mL, excluding menstrual bleeding), transfusion, or use of blood products within 1 month prior to screening; 12. Intolerance to venipuncture and\u002For history of syncope due to blood or needle exposure; 13. Pregnant or lactating women, or participants unwilling to use effective non-pharmacological contraception during the trial; 14. Inability to use contraception for 6 months after trial completion; 15.Inability to comply with dietary restrictions or nutritional guidelines; 16.Alcohol abuse or regular alcohol consumption (\\>14 units\u002Fweek; 1 unit ≈ 200 mL beer \\[5%\\], 25 mL spirits \\[40%\\], or 85 mL wine \\[12%\\]) within 6 months before screening, or unwillingness to abstain from alcohol during the trial; 17. Participants with unstable psychiatric disorders, in the investigator's opinion, who cannot cooperate with the study; 18. Any other condition deemed by the investigator to compromise study compliance or safety.","ALL","18 Years","70 Years",{"count":20,"type":21},11,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a randomized, double-blind, placebo-controlled, single-center Phase IIa clinical study.",[27],"Cadmium Exceeds the Standard",[29,30,31,32,33],"Cadmium","Cadmium Poisoning","Therapeutics","Drugs, Investigational","GMDTC","RECRUITING","2025-08-25",{"date":37,"type":38},"2025-09-02","ACTUAL",{"date":40,"type":38},"2025-07-07",{"date":42,"type":21},"2025-12-30",{"name":44,"class":45},"Guangdong Jianersheng Pharmaceutical Technology Co., Ltd.","OTHER"]