The Safety and Efficacy of GMDTC for Injection in Subjects With Elevated Cadmium Levels

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Cadmium Exceeds the Standard

In brief

This is a randomized, double-blind, placebo-controlled, single-center Phase IIa clinical study.

Key facts

Study ID: NCT07057414
Run by: Guangdong Jianersheng Pharmaceutical Technology Co., Ltd.
People needed: 11
Starts: 2025-07-07
Expected to finish: 2025-12-30
Last updated by the study team: 2025-09-02

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Study participants must meet all of the following criteria to be enrolled in this trial:
Voluntarily sign the informed consent form, aged between 18 and 70 years (inclusive), regardless of gender;
Single morning urine cadmium >5 μg/g creatinine (with creatinine concentration ≥0.3 g/L and ≤3 g/L);
eGFR ≥30 mL/min/1.73 m² (calculated using the CKD-EPI formula).

You may not qualify if…

Participants who meet any of the following criteria will be excluded from this study:
Currently suffering from any clinically significant disease that, in the investigator's judgment, poses a safety risk for participation in this clinical trial;
Patients with a history of kidney disease requiring hemodialysis;
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);
Previous diagnosis of diabetes with poorly controlled blood glucose;
History of conditions predisposing to hypokalemia (e.g., periodic hypokalemia, primary aldosteronism);
High-risk uncontrolled arrhythmia within the past 6 months, including:
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) <50%; 7.Prolonged QT/QTc interval at screening/baseline (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/or 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/week; 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.

Where it is running

Guangdong Provincial Hospital for Occupational Disease Prevention and Treatment — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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