RecruitingPhase 2

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

China11 participantsStarted 2025-07-07

Plain-language summary

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

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;
✕. History of conditions predisposing to hypokalemia (e.g., periodic hypokalemia, primary aldosteronism);
✕. High-risk uncontrolled arrhythmia within the past 6 months, including:

Pharmacodynamic Parameters , 24-hour urinary cadmium

Timeframe: Evaluated at pre-dose (Day-1) and post-dose (Day1-Day6, Day8-Day13)

NCT IDNCT07057414

SponsorGuangdong Jianersheng Pharmaceutical Technology Co., Ltd.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-29

Xiaojiang Tang, PhD