Usage and dosage
The study nurse administered intravenous injection to the subjects and the administration time was 10min.
Three dose groups were preset for this study, with subjects scheduled to receive SGC001 300 mg, 600 mg, and 900 mg or matching volume placebo intravenously on day 1 (D1).
The preparation of drugs is carried out at room temperature, and the preparation and use process does not need to avoid light. If the device cannot be used in time, store it at 2-8℃ and destroy it after 24 hours.
SGC001 injection and SGC001 injection (placebo) use information is as follows:
Dosage（mg） 300 600 900
Volume（ml） 7.5 15 22.5
Quantity（vial） 1 2 3
Infusion pump Setting Injection Volume（mL) 7.5 15 22.5
Note: No dilution required
Note：Specification：400mg/10mL/ vial
To be eligible for access to an investigational product, patients must meet the following criteria:
• Suffer from a serious or immediately life-threatening disease or condition.
• Have undergone appropriate standard treatments without success and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition.
• Are ineligible for participation in any ongoing clinical study of the investigational product, which includes lack of access due to geographic limitations.
• The patient has a disease for which there is sufficient evidence of a projected benefit from the use of the investigational product and the benefit outweighs the known or anticipated risks.
• There is adequate information to support appropriate dosing for a special population patients such as pediatric, elderly, renal or hepatic disease, etc.
• Any other pertinent medical criteria for access to the investigational product, as established by the COMPANY NAME clinically or medically responsible individual.