[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597355":3},{"organization":4,"outcomesModule":7,"designInfo":75,"detailedDescription":87,"studyPopulation":74,"armGroups":88,"interventions":101,"overallOfficials":111,"centralContacts":118,"locations":128,"responsibleParty":149,"collaborators":151,"id":154,"slug":155,"hasResults":156,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":74,"eligibilityCriteria":160,"healthyVolunteers":156,"sex":161,"minAge":162,"maxAge":163,"enrollmentInfo":164,"targetDuration":74,"studyType":167,"phases":168,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":130,"whyStopped":74,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":188},{"fullName":5,"class":6},"Guangdong Jianersheng Pharmaceutical Technology Co., Ltd.","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":74},[9],{"measure":10,"description":11,"timeFrame":12},"Pharmacodynamic Parameters , 24-hour urinary cadmium","24-hour urinary cadmium excretion before and after drug administration(μg\u002FL)","Evaluated at pre-dose (Day-1) and post-dose (Day1-Day6, Day8-Day13)",[14,18,22,25,29,32,35,38,41,44,48,51,54,58,61,65,68,71],{"measure":15,"description":16,"timeFrame":17},"Adverse Events (AEs)","Clinical safety assessments during the trial will include: 1) all spontaneously reported and directly observed adverse events (AEs) and serious adverse events (SAEs); 2) any clinically significant changes in vital signs (as determined by the investigator); 3) clinically significant abnormalities (as determined by the investigator) observed during physical examinations, laboratory tests, electrocardiograms (ECG), cardiac ultrasound, abdominal ultrasound, thyroid ultrasound, chest CT scans, ophthalmologic examinations, auditory tests, and olfactory tests, with AE severity graded according to CTCAE v5.0 standards.","Within 30 days after the last dose administration",{"measure":19,"description":20,"timeFrame":21},"Pharmacodynamic Parameters , Urinary Cadmium and Lead Levels","urinary Cadmium and Lead Levels before and after drug administration (μg\u002Fg Creatinine)","Evaluated at pre-dose (Day1) and post-dose (Day6, Day8, Day13, Day15)",{"measure":23,"description":24,"timeFrame":12},"Pharmacodynamic Parameters , 24-Hour Urinary Lead and Copper","24-Hour Urinary Lead and Copper Excretion before and after drug administration(μg\u002FL)",{"measure":26,"description":27,"timeFrame":28},"Pharmacodynamic Parameters , Blood Heavy Metal\u002FMetalloid Levels(Pb, As, Hg, Cr, Mn)","Blood Heavy Metal\u002FMetalloid Levels (Pb, As, Hg, Cr, Mn) before and after drug administration(μg\u002FL)","Evaluated at pre-dose (Day1) and post-dose (Day6, Day8, Day13)",{"measure":30,"description":31,"timeFrame":28},"Pharmacodynamic Parameters , Blood Heavy Metal\u002FMetalloid Levels(Cu, Zn)","Blood Heavy Metal\u002FMetalloid Levels (Cu, Zn) before and after drug administration(mg\u002FL)",{"measure":33,"description":34,"timeFrame":21},"Pharmacodynamic Parameters , Renal Function Biomarker Levels(Creatinine-corrected urinary β2-MG, Creatinine-corrected urinary URBP)","Renal Function Biomarker Levels (Creatinine-corrected urinary β2-microglobulin, Creatinine-corrected URBP ) before and after drug administration (μg\u002Fg Creatinine)",{"measure":36,"description":37,"timeFrame":21},"Pharmacodynamic Parameters , Renal Function Biomarker Levels(β2-MG, URBP)","Renal Function Biomarker Levels (Urinary β2-microglobulin (β2MG), Urinary retinol-binding protein (URBP)) before and after drug administration(μg\u002FL)",{"measure":39,"description":40,"timeFrame":21},"Pharmacodynamic Parameters , Renal Function Biomarker Levels(α1-MG)","Renal Function Biomarker Levels (Urinary α1-microglobulin) before and after drug administration(mg\u002FL)",{"measure":42,"description":43,"timeFrame":21},"Pharmacodynamic Parameters , Renal Function Biomarker Levels(NAG)","Renal Function Biomarker Levels (Urinary N-acetyl-β-D-glucosaminidase (NAG) ) before and after drug administration(U\u002FL)",{"measure":45,"description":46,"timeFrame":47},"Pharmacodynamic Parameters, Bone Metabolism Biomarker Levels(PTH)","Bone Metabolism Biomarker Levels(Parathyroid hormone (PTH)) before and after drug administration(pg\u002FmL)","Evaluated at Pre-dose (Screening Period) and post-dose (Day6, Day13)",{"measure":49,"description":50,"timeFrame":47},"Pharmacodynamic Parameters, Bone Metabolism Biomarker Levels(25(OH)D, P1NP, CTX)","Bone Metabolism Biomarker Levels(25-Hydroxyvitamin D, Serum procollagen type I N-terminal propeptide (P1NP), Serum C-terminal telopeptide of type I collagen (CTX)) before and after drug administration(ng\u002FmL)",{"measure":52,"description":53,"timeFrame":47},"Pharmacodynamic Parameters, Bone Metabolism Biomarker Levels(ALP)","Bone Metabolism Biomarker Levels(Serum alkaline phosphatase (ALP)) before and after drug administration(U\u002FL)",{"measure":55,"description":56,"timeFrame":57},"Pharmacodynamic Parameters , urinary cadmium Levels","Change in Urinary Cadmium Levels before and after drug administration (μg\u002Fg Creatinine)","Evaluated from Baseline (Pre-dose Day1) to First Void Post-dose (Day1-Day5 & Day8-Day12)",{"measure":59,"description":60,"timeFrame":28},"Pharmacodynamic Parameters , Blood Cadmium Concentration","Blood Cadmium (Cd) Concentration before and after drug administration(μg\u002FL)",{"measure":62,"description":63,"timeFrame":64},"Pharmacokinetic Parameters , Tmax","Time to reach peak concentration (observed value)","Evaluated at baseline, during drug infusion, and within 24 hours after drug administration",{"measure":66,"description":67,"timeFrame":64},"Pharmacokinetic Parameters , Cmax","Peak concentration (observed value)",{"measure":69,"description":70,"timeFrame":64},"Pharmacokinetic Parameters , λz","Apparent terminal elimination rate constant, derived from semi-log linear regression of elimination phase concentration points.",{"measure":72,"description":73,"timeFrame":64},"Pharmacokinetic Parameters , t1\u002F2","Apparent terminal elimination half-life, calculated using the following equation: t1\u002F2 = Ln(2) \u002F λz",null,{"allocation":76,"interventionModel":77,"interventionModelDescription":78,"primaryPurpose":79,"observationalModel":74,"timePerspective":74,"maskingInfo":80},"RANDOMIZED","PARALLEL","This study anticipates 11 subjects per dose group (including 3 placebo controls), with the total sample size to be determined based on actual study progress.","TREATMENT",{"masking":81,"maskingDescription":74,"whoMasked":82},"QUADRUPLE",[83,84,85,86],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","The primary objective of this study is to evaluate the pharmacodynamic characteristics of GMDTC for Injection in subjects with elevated cadmium levels after administration, while the secondary objectives are to assess the safety, tolerability and pharmacokinetic profile of GMDTC for Injection following multiple-dose administration in the same population; based on the results from Phase I single- and multiple-dose studies, the initial dose group in this trial is set at 2000 mg with a concentration of 4 mg\u002FmL, where the first 4 participants (including 3 in the treatment group and 1 in the placebo group) will be enrolled first, and subsequent participants in the same dose group can only continue enrollment after investigators complete the 72-hour post-dose safety and tolerability assessments and confirm favorable results, with the SMC meeting to determine subsequent study plans including but not limited to dose escalation, concentration adjustment or increased treatment duration after completion of observation for each dose group.",[89,95],{"label":90,"type":91,"description":92,"interventionNames":93},"GMDTC Group","EXPERIMENTAL","Participants randomized to the GMDTC Group will receive daily administrations (GMDTC for Injection ) after breakfast from Day 1 to Day 5 and Day 8 to Day 12.",[94],"Drug: GMDTC for injection",{"label":96,"type":97,"description":98,"interventionNames":99},"Placebo Group","PLACEBO_COMPARATOR","Participants randomized to the Placebo Group will receive daily administrations (normal saline for Injection ) after breakfast from Day 1 to Day 5 and Day 8 to Day 12.",[100],"Other: 0.9% Sodium Chloride Injection(0.9% NaCl)",[102,107],{"type":103,"name":104,"description":105,"armGroupLabels":106,"otherNames":74},"DRUG","GMDTC for injection","GMDTC for Injection with a specification of 0.5g\u002Fvial, and administered by intravenous infusion. According to the drug preparation SOP , Using 0.9% physiological saline to achieve the required concentration for each dose group (e.g., The initial dose group: 2 g reconstituted in 500 mL, with each 1 g reconstituted in 250 mL, resulting in a 4 mg\u002FmL concentration.). All infusion-related reactions must be documented. Drug preparation must be performed by an non-blind investigator independent of the study to maintain blinding integrity for other study personnel.",[90],{"type":6,"name":108,"description":109,"armGroupLabels":110,"otherNames":74},"0.9% Sodium Chloride Injection(0.9% NaCl)","0.9% Sodium Chloride Injection with a specification of 250mL\u002Fbag, and administered by intravenous infusion. The infusion should be strictly adhering to the assigned dosage. All infusion-related reactions must be documented. Drug preparation must be performed by an non-blind investigator independent of the study to maintain blinding integrity for other study personnel.",[96],[112,116],{"name":113,"affiliation":114,"role":115},"Yanyan Wang, M.Med.","Guangdong Provincial Hospital for Occupational Disease Prevention and Treatment","PRINCIPAL_INVESTIGATOR",{"name":117,"affiliation":114,"role":115},"Ming Huang, PhD",[119,124],{"name":120,"role":121,"phone":122,"phoneExt":74,"email":123},"Xiaojiang Tang, PhD","CONTACT","13719282259","tangxiaojiang@jesgmdtc.com",{"name":125,"role":121,"phone":126,"phoneExt":74,"email":127},"Wei Hu, PhD","15011814225","huwei@jesgmdtc.com",[129],{"facility":114,"status":130,"city":131,"state":132,"zip":133,"country":134,"countryCode":135,"cosmosGeoPoint":136,"geoPoint":141,"contacts":142},"RECRUITING","Guangzhou","Guangdong","510300","China","CN",{"type":137,"coordinates":138},"Point",[139,140],113.25,23.11667,{"lat":140,"lon":139},[143,146],{"name":113,"role":121,"phone":144,"phoneExt":74,"email":145},"15876522725","ilvyan@126.com",{"name":117,"role":121,"phone":147,"phoneExt":74,"email":148},"18922195007","echo.echo@126.com",{"type":150,"investigatorFullName":74,"investigatorTitle":74,"investigatorAffiliation":74,"oldNameTitle":74,"oldOrganization":74},"SPONSOR",[152],{"name":114,"class":153},"UNKNOWN","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":165,"type":166},11,"ESTIMATED","INTERVENTIONAL",[169],"PHASE2","This is a randomized, double-blind, placebo-controlled, single-center Phase IIa clinical study.",[172],"Cadmium Exceeds the Standard",[174,175,176,177,178],"Cadmium","Cadmium Poisoning","Therapeutics","Drugs, Investigational","GMDTC","2025-08-25",{"date":181,"type":182},"2025-09-02","ACTUAL",{"date":184,"type":182},"2025-07-07",{"date":186,"type":166},"2025-12-30",{"name":5,"class":6},1]