Acute Pancreatitis
Conditions
Keywords
SGC001, Predicted Severe Acute Pancreatitis, Acute Pancreatitis
Brief summary
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.
Interventions
DRUGSGC001 injection
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
DRUGPlacebo
Specification: 0mg(10mL)per vial Dosage Administration: 0mg as a single intravenous infusion Infusion Duration:60±10minutes
Sponsors
Beijing Sungen Biomedical Technology Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part A: Safety Adverse Event (AE) | Part A Safety: Day 0- Day 85 | 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: Day 1-Day 15 | — |
Secondary
| Measure | Time frame |
|---|---|
| Part B: Days alive without SIRS within 7 days and 14 days after randomization | Part B: Day 1-Day 15 |
Countries
China
Contacts
CONTACTLily Shi
Outcome results
None listed