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

NCT07057414 | Recruiting Phase 2

• 1 other identifier: GuangdongPharm IIa
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cadmium Exceeds the Standard

Keywords

Cadmium; Cadmium Poisoning; Therapeutics; Drugs, Investigational; GMDTC

Outcome Measures

Primary Outcomes (1)

• Pharmacodynamic Parameters , 24-hour urinary cadmium

  24-hour urinary cadmium excretion before and after drug administration(μg/L)

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

Secondary Outcomes (18)

• Adverse Events (AEs)

  Within 30 days after the last dose administration

• Pharmacodynamic Parameters , Urinary Cadmium and Lead Levels

  Evaluated at pre-dose (Day1) and post-dose (Day6, Day8, Day13, Day15)

• Pharmacodynamic Parameters , 24-Hour Urinary Lead and Copper

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

• Pharmacodynamic Parameters , Blood Heavy Metal/Metalloid Levels(Pb, As, Hg, Cr, Mn)

  Evaluated at pre-dose (Day1) and post-dose (Day6, Day8, Day13)

• Pharmacodynamic Parameters , Blood Heavy Metal/Metalloid Levels(Cu, Zn)

  Evaluated at pre-dose (Day1) and post-dose (Day6, Day8, Day13)

Study Arms (2)

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.

Drug: GMDTC for injection

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.

Other: 0.9% Sodium Chloride Injection(0.9% NaCl)

Interventions

GMDTC for injection DRUG

GMDTC 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.

GMDTC Group

0.9% Sodium Chloride Injection(0.9% NaCl) OTHER

0.9% 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.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Guangdong Jianersheng Pharmaceutical Technology Co., Ltd.: lead
• Guangdong Provincial Hospital for Occupational Disease Prevention and Treatment: collaborator

Study Sites (1)

Guangdong Provincial Hospital for Occupational Disease Prevention and Treatment

Guangzhou, Guangdong, 510300, China

RECRUITING

Related Publications (1)

• Tang X, Zhu J, Zhong Z, Luo M, Li G, Gong Z, Zhang C, Fei F, Ruan X, Zhou J, Liu G, Li G, Olson J, Ren X. Mobilization and removing of cadmium from kidney by GMDTC utilizing renal glucose reabsorption pathway. Toxicol Appl Pharmacol. 2016 Aug 15;305:143-152. doi: 10.1016/j.taap.2016.06.001. Epub 2016 Jun 6.

  PMID: 27282297 BACKGROUND

MeSH Terms

Conditions

Cadmium Poisoning

Interventions

Injections; Sodium Chloride

Condition Hierarchy (Ancestors)

Heavy Metal Poisoning; Poisoning; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Yanyan Wang, M.Med.

  Guangdong Provincial Hospital for Occupational Disease Prevention and Treatment

  PRINCIPAL INVESTIGATOR

• Ming Huang, PhD

  Guangdong Provincial Hospital for Occupational Disease Prevention and Treatment

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaojiang Tang, PhD

CONTACT

13719282259; tangxiaojiang@jesgmdtc.com

Wei Hu, PhD

CONTACT

15011814225; huwei@jesgmdtc.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: July 9, 2025
• Study Start: July 7, 2025
• Primary Completion: October 29, 2025
• Study Completion: December 30, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)