This is a randomized, double-blind, placebo-controlled, single-center Phase IIa clinical study.
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).
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;
Parallel
GMDTC for injection
DrugGMDTC for Injection with a specification of 0.5g/vial, 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/mL 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.
0.9% Sodium Chloride Injection(0.9% NaCl)
Other intervention0.9% Sodium Chloride Injection with a specification of 250mL/bag, 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.
Pharmacodynamic Parameters , 24-hour urinary cadmium
24-hour urinary cadmium excretion before and after drug administration(μg/L)
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.
Pharmacodynamic Parameters , Urinary Cadmium and Lead Levels
urinary Cadmium and Lead Levels before and after drug administration (μg/g Creatinine)
Pharmacodynamic Parameters , 24-Hour Urinary Lead and Copper
24-Hour Urinary Lead and Copper Excretion before and after drug administration(μg/L)
Pharmacodynamic Parameters , Blood Heavy Metal/Metalloid Levels(Pb, As, Hg, Cr, Mn)
Blood Heavy Metal/Metalloid Levels (Pb, As, Hg, Cr, Mn) before and after drug administration(μg/L)
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Guangdong Jianersheng Pharmaceutical Technology Co., Ltd.
Lead sponsor
Guangdong Provincial Hospital for Occupational Disease Prevention and Treatment
Collaborator
