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RECRUITING
NCT07057414
PHASE2

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

Sponsor: Guangdong Jianersheng Pharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

OTHER

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