SGC001 is being tested to help predicted severe acute pancreatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial tests SGC001 as an add-on to standard care in patients with predicted severe acute pancreatitis. The study has two parts: a dose-escalation safety/tolerability portion (Part A) and a dose-exploration efficacy portion (Part B). Participants are randomly assigned to receive a single injection of SGC001 or placebo. Primary goals are safety, tolerability, and pharmacodynamics, with Part B also exploring preliminary efficacy signals.

Why it matters

Who can join: the full rules

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.

Where it's running

• General Hospital of the Eastern Theater Command of the Chinese People's Liberation Army
  Nanjing, China Recruiting
• West China Hospital, Sichuan University
  Chengdu, China Not yet recruiting
• The Affiliated Hospital of Guizhou Medical University
  Guizhou, China Not yet recruiting
• Zhejiang Provincial People's Hospital
  Hangzhou, China Not yet recruiting
• The Second Affiliated Hospital of Anhui Medical University
  Hefei, China Not yet recruiting
• The First Affiliated Hospital of Henan University of Science and Technology
  Luoyang, China Not yet recruiting

Study contacts

• Study coordinator: Lily Shi
• Email: liping.shi@hotgen.com.cn
• Phone: +86 13381070876

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Fecal microbiota transplant to prevent infections after late-phase severe acute pancreatitis

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• How often splanchnic vein clots occur in acute pancreatitis and whether they relate to disease severity

  This project will see if people with acute pancreatitis develop blood clots in the splenic, portal, or superior mesenteric veins and whether those clots are linked to more severe illness.

  Recruiting Asian Institute of Gastroenterology, India · Hyderabad, Telangana · NCT07322978

• Fecal microbiota transplant for people with moderate to severe acute pancreatitis

  This trial will test whether a fecal microbiota transplant (FMT) can reduce late complications in adults with moderate to severe acute pancreatitis.

  Recruiting at 2 sites Changhai Hospital · Shanghai, Shanghai Municipality and 1 other locations · NCT07153809

• Blood markers to detect infected pancreatic necrosis

  We will test whether specific blood markers can help predict or diagnose infected pancreatic necrosis in adults with necrotizing pancreatitis.

  Recruiting University of Minnesota · Minneapolis, Minnesota · NCT06899087

• Cryotechnology for removing necrotic pancreatic tissue

  This study is testing a new freezing technique to see if it can help doctors remove dead tissue from the pancreas more effectively in patients with severe pancreatitis.

  Recruiting Brigham and Women's Hospital · Boston, Massachusetts · NCT06553651

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.