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The Safety and Efficacy of GMDTC for Injection in Subjects With Elevated Cadmium Levels
Sponsor: Guangdong Jianersheng Pharmaceutical Technology Co., Ltd.
Summary
This is a randomized, double-blind, placebo-controlled, single-center Phase IIa clinical study.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
11
Start Date
2025-07-07
Completion Date
2025-12-30
Last Updated
2025-09-02
Healthy Volunteers
No
Conditions
Interventions
GMDTC for injection
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.
0.9% Sodium Chloride Injection(0.9% NaCl)
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.
Locations (1)
Guangdong Provincial Hospital for Occupational Disease Prevention and Treatment
Guangzhou, Guangdong, China