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

NCT07057414 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-09-02

No results posted yet for this study

Summary

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

Conditions

  • Cadmium Exceeds the Standard

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.

Sponsors & Collaborators

  • Guangdong Provincial Hospital for Occupational Disease Prevention and Treatment

    collaborator UNKNOWN

  • Guangdong Jianersheng Pharmaceutical Technology Co., Ltd.

    lead OTHER

Principal Investigators

  • Yanyan Wang, M.Med. · Guangdong Provincial Hospital for Occupational Disease Prevention and Treatment

  • Ming Huang, PhD · Guangdong Provincial Hospital for Occupational Disease Prevention and Treatment

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-07
Primary Completion
2025-10-29
Completion
2025-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07057414 on ClinicalTrials.gov