This is an early phase clinical study. Patients who are at high risk of developing severe acute pancreatitis will be screened. Participants will be randomly assigned to receive either SGC001 injection or a placebo injection that contains no active medicine. The study will check how safe and well tolerated SGC001 is, how the body processes this study drug, its biological effects, and whether it may help treat this condition. The study consists of Part A, a dose escalation phase primarily focused on safety and tolerability, and Part B, a dose exploration phase primarily focused on efficacy, both administered as a single add on dose to standard care in patients with predicted severe acute pancreatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
129
Specification:400mg (10mL) per vial Part A: Dosage and Administration:300mg or 600mg, other dosage determined by the safety review committee (SRC) administered as a single intravenous infusion Infusion Duration:60±10minutes Part B: Based on clinical pharmacokinetic, safety and/or efficacy data obtained from the Part A dose escalation phase, the SRC will select 1 or 2 optimal dose cohorts. Infusion Duration:60±10minutes administered as a single intravenous infusion
Specification: 0mg(10mL)per vial Dosage Administration: 0mg as a single intravenous infusion Infusion Duration:60±10minutes
West China Hospital, Sichuan University
Chengdu, China
The Affiliated Hospital of Guizhou Medical University
Guizhou, China
Zhejiang Provincial People's Hospital
Hangzhou, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, China
The First Affiliated Hospital of Nanchang University
Nanchang, China
General Hospital of the Eastern Theater Command of the Chinese People's Liberation Army
Nanjing, China
Li Huili Hospital, Ningbo Medical Center
Ningbo, China
Shanghai General Hospital
Shanghai, China
General Hospital of Northern Theater Command of the Chinese People's Liberation Army
Shenyang, China
...and 5 more locations
Part A: Safety Adverse Event (AE)
Part A of this trial mainly analyzes on treatment-emergent adverse events (TEAEs) and treatment-related adverse events (TRAEs), including clinically significant changes in vital signs, physical examination, electrocardiogram, and clinical laboratory tests, as graded by NCI CTCAE V6.0.
Time frame: Part A Safety: Day 0- Day 85
Part B: Days alive free of organ failure within 14 days post-randomization
Time frame: Part B: Day 1-Day 15
Part B: Days alive without SIRS within 7 days and 14 days after randomization
Time frame: Part B: Day 1-Day 15
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