Study of SGC001 Injection for Predicted Severe Acute Pancreatitis to Assess Safety, Tolerability and Preliminary Efficacy

A Randomized, Placebo-Controlled Phase IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics and Preliminary Efficacy of SGC001 Injection in Participants With Predicted Severe Acute Pancreatitis.

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.

Inclusion Criteria:

1. Aged 18 to 75 years inclusive, with no restriction on gender
2. 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.
3. Meet the manifestations of predicted severe acute pancreatitis (AP)

Exclusion Criteria:

1. The exact onset time of abdominal pain cannot be accurately determined.
2. History of endoscopic retrograde cholangiopancreatography (ERCP) performed within 7 days prior to screening;
3. Received extracorporeal membrane oxygenation (ECMO) or renal replacement therapy prior to admission;
4. Requirement for emergency surgery, ERCP, ECMO, renal replacement therapy or plasma exchange immediately upon admission;
5. Having a known medical history of severe cardiovascular, respiratory, renal, hepatic, hematological or immune diseases;
6. Subjects with current malignancy or a prior history of malignant tumors, except for basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder tumors or carcinoma in situ of the cervix that have been cured for at least 5 years.
7. Subjects suffering from severe psychiatric disorders, cognitive impairment caused by severe social environmental factors, or any other conditions that the investigator judges may lead to poor protocol compliance or expose the subject to additional safety risks during the trial.
8. Administration of live vaccines within 1 month prior to screening;
9. Female subjects who are pregnant or breastfeeding; female subjects of childbearing potential who have had unprotected sexual intercourse within 1 month prior to screening, or with a positive pregnancy test at screening; subjects (or their partners) who plan to conceive, donate sperm or oocytes throughout the study period and within 6 months after study completion; subjects who refuse to use one or more effective contraceptive methods during the study and for 6 months following the end of the study.