GMDTC injection for people with high 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

This study will test whether GMDTC injections can lower high cadmium levels and are safe for adults with elevated urinary cadmium.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Guangdong Jianersheng Pharmaceutical Technology Co., Ltd. (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07057414 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled, single-center Phase IIa trial testing multiple doses of GMDTC for injection in adults with elevated cadmium. The primary goal is to characterize the drug's pharmacodynamic effects on cadmium levels, with secondary objectives to monitor safety, tolerability, and pharmacokinetics after repeated dosing. The initial dose cohort is 2000 mg (4 mg/mL) with a sentinel group of four participants (three active, one placebo) and a 72-hour post-dose safety review before further enrollment. A safety monitoring committee will review findings to decide on dose escalation, concentration changes, or treatment duration adjustments.

Who should consider this trial

Good fit: Adults aged 18–70 with a single morning urine cadmium >5 μg/g creatinine (creatinine 0.3–3 g/L) and eGFR ≥30 mL/min/1.73 m² are the intended participants.

Not a fit: Patients with severe kidney disease requiring dialysis, known severe infusion-related allergies or hypersensitivity to product components, or other major uncontrolled medical conditions may not benefit and are excluded.

Why it matters

Potential benefit: If successful, GMDTC could help reduce body cadmium burden and lower health risks associated with cadmium exposure.

How similar studies have performed: Phase I single- and multiple-dose studies have been conducted, but larger efficacy data remain limited.

Eligibility criteria

Inclusion Criteria:

Study participants must meet all of the following criteria to be enrolled in this trial:

1. Voluntarily sign the informed consent form, aged between 18 and 70 years (inclusive), regardless of gender;
2. Single morning urine cadmium \>5 μg/g creatinine (with creatinine concentration ≥0.3 g/L and ≤3 g/L);
3. eGFR ≥30 mL/min/1.73 m² (calculated using the CKD-EPI formula).

Exclusion Criteria:

Participants who meet any of the following criteria will be excluded from this study:

1. Currently suffering from any clinically significant disease that, in the investigator's judgment, poses a safety risk for participation in this clinical trial;
2. Patients with a history of kidney disease requiring hemodialysis;
3. 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);
4. Previous diagnosis of diabetes with poorly controlled blood glucose;
5. History of conditions predisposing to hypokalemia (e.g., periodic hypokalemia, primary aldosteronism);
6. High-risk uncontrolled arrhythmia within the past 6 months, including:

1\) 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 this trial is running

Guangzhou, Guangdong

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

Study contacts

• Principal investigator: Yanyan Wang, M.Med. — Guangdong Provincial Hospital for Occupational Disease Prevention and Treatment
• Study coordinator: Xiaojiang Tang, PhD

Conditions Cadmium Exceeds the Standard; Cadmium; Cadmium Poisoning; Therapeutics; Drugs, Investigational; GMDTC