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Safety Study of GMDTC Injection in Participants With Excessive Cadmium

NCT06199349 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-02-20

No results posted yet for this study

Summary

This trial is a randomized, double-blind, single-center, single-dose escalating Phase I clinical trial designed to evaluate the safety, tolerability, and pharmacokinetic characteristics of GMDTC for injection after repeated administration in people with excessive cadmium levels.

Conditions

  • Cadmium Exceeds the Standard

Interventions

DRUG

GMDTC for injection

GMDTC for injection with a specification of 0.5g/vial, 500mg,1000mg,2000mg, and administered by intravenous infusion. Using 0.9% physiological saline (0.5g will be prepared with 250mL injection solution to achieve a concentration of 2mg/mL). Using an infusion pump at a rate of 4mL/min according to the dosage, and any infusion reactions will be recorded. The injection solution for both the experimental and placebo groups should be prepared by a non-blind investigator independent of the trial.

OTHER

Normal saline

0.9% physiological saline for injection with a specification of 250ml/bag, and administered by intravenous infusion. Using an infusion pump at a rate of 4mL/min according to the dosage, and any infusion reactions will be recorded. The injection solution for both the experimental and placebo groups should be prepared by a non-blind investigator independent of the trial

Sponsors & Collaborators

  • Jianersheng (Zhuhai) Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yan Lai · Hunan Occupational Disease Prevention and Control Institute

  • Fang Pei, PhD-c · Hunan Occupational Disease Prevention and Control Institute

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-08
Primary Completion
2024-10-21
Completion
2024-12-05

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 NCT06199349 on ClinicalTrials.gov