11
Participants
Start Date
July 7, 2025
Primary Completion Date
October 29, 2025
Study Completion Date
December 30, 2025
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.
RECRUITING
Guangdong Provincial Hospital for Occupational Disease Prevention and Treatment, Guangzhou
Guangdong Provincial Hospital for Occupational Disease Prevention and Treatment
UNKNOWN
Guangdong Jianersheng Pharmaceutical Technology Co., Ltd.
OTHER