Safety Study of GMDTC Injection in Healthy Participants

PHASE1CompletedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

January 30, 2023

Primary Completion Date

June 30, 2023

Study Completion Date

July 30, 2023

Conditions
Cadmium Exposure
Interventions
DRUG

GMDTC for injection

GMDTC for injection with a specification of 0.5g/vial, 250mg,500mg,850mg,1200mg,1600mg,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.

Trial Locations (1)

410000

Hunan Occupational Disease Prevention and Control Institute, Changsha

All Listed Sponsors
lead

Jianersheng (Zhuhai) Pharmaceutical Technology Co., Ltd.

INDUSTRY