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.
Aged 18 to 75 years inclusive, with no restriction on gender
Meet the diagnostic criteria for acute pancreatitis (AP) specified in the IAP Guidelines for the Management of Acute Pancreatitis (2025 Revision), i.e., satisfying at least two of the following three criteria: Clinical criterion: Acute epigastric abdominal pain; Biochemical criterion: Elevated pancreatic enzymes (serum lipase or amylase level more than 3 times the upper limit of normal (ULN)); Imaging criterion: Abdominal imaging examination (computed tomography (CT) or ultrasound) demonstrating findings consistent with acute pancreatic inflammation, with or without necrosis.
Meet the manifestations of predicted severe acute pancreatitis (AP)
The exact onset time of abdominal pain cannot be accurately determined.
History of endoscopic retrograde cholangiopancreatography (ERCP) performed within 7 days prior to screening;
Received extracorporeal membrane oxygenation (ECMO) or renal replacement therapy prior to admission;
Requirement for emergency surgery, ERCP, ECMO, renal replacement therapy or plasma exchange immediately upon admission;
Parallel
SGC001 injection
DrugSpecification: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
Placebo
DrugSpecification: 0mg(10mL)per vial Dosage Administration: 0mg as a single intravenous infusion Infusion Duration:60±10minutes
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.
Part B: Days alive free of organ failure within 14 days post-randomization
Part B: Days alive without SIRS within 7 days and 14 days after randomization
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