Actively Recruiting
The Safety and Efficacy of GMDTC for Injection in Subjects With Elevated Cadmium Levels
Led by Guangdong Jianersheng Pharmaceutical Technology Co., Ltd. · Updated on 2025-09-02
11
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
G
Guangdong Jianersheng Pharmaceutical Technology Co., Ltd.
Lead Sponsor
G
Guangdong Provincial Hospital for Occupational Disease Prevention and Treatment
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a randomized, double-blind, placebo-controlled, single-center Phase IIa clinical study.
CONDITIONS
Official Title
The Safety and Efficacy of GMDTC for Injection in Subjects With Elevated Cadmium Levels
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 70 years, any gender
- Voluntarily signed informed consent
- Single morning urine cadmium level greater than 5 µg/g creatinine (creatinine between 0.3 g/L and 3 g/L)
- Estimated glomerular filtration rate (eGFR) of 30 mL/min/1.73 m² or higher calculated by CKD-EPI formula
You will not qualify if you...
- Presence of any clinically significant disease that poses safety risks
- History of kidney disease requiring hemodialysis
- History of severe infusion-related allergic reactions or allergies to three or more substances
- Known hypersensitivity to any component of the study drug (e.g., disodium edetate, mannitol)
- Poorly controlled diabetes
- History of conditions leading to hypokalemia (e.g., periodic hypokalemia, primary aldosteronism)
- High-risk uncontrolled arrhythmia within past 6 months including resting atrial tachycardia over 100 bpm, significant ventricular arrhythmia, high-grade atrioventricular block, NYHA Class IV heart failure, or left ventricular ejection fraction below 50%
- Prolonged QT/QTc interval at screening or family history of long QT syndrome
- Use of medications or supplements that may interact with the study drug within 14 days prior to screening
- Participation in other clinical trials with investigational drugs or devices within 3 months
- Major surgery within 4 weeks before screening or planned surgery during the trial
- Blood donation, significant blood loss, transfusion, or blood product use within 1 month prior to screening
- Intolerance to venipuncture or history of fainting related to blood or needles
- Pregnant or lactating women, or unwillingness to use effective contraception during the trial
- Inability to use contraception for 6 months after trial completion
- Unable to follow dietary restrictions or nutritional guidelines
- Alcohol abuse or regular consumption over 14 units per week within 6 months prior to screening or unwillingness to abstain during the trial
- Unstable psychiatric disorders preventing cooperation
- Any other condition that could compromise compliance or safety as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Guangdong Provincial Hospital for Occupational Disease Prevention and Treatment
Guangzhou, Guangdong, China, 510300
Actively Recruiting
Research Team
X
Xiaojiang Tang, PhD
CONTACT
W
Wei Hu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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