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NCT Number: NCT07803965

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

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.

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Key information

Conditions

Acute Pancreatitis Digestive System Diseases Pancreatic Diseases Pancreatitis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

West China Hospital, Sichuan University, Chengdu, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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;
  • Having a known medical history of severe cardiovascular, respiratory, renal, hepatic, hematological or immune diseases;
  • 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.
  • 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.
  • Administration of live vaccines within 1 month prior to screening;
  • 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.

Treatment and study plan

SGC001 injection

Drug

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

Placebo

Drug

Specification: 0mg(10mL)per vial Dosage Administration: 0mg as a single intravenous infusion Infusion Duration:60±10minutes

Primary outcomes

  1. Part A: Safety Adverse Event (AE)

    Time frame: 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.

  2. Part B: Days alive free of organ failure within 14 days post-randomization

    Time frame: Part B: Day 1-Day 15

Secondary outcomes

  1. Part B: Days alive without SIRS within 7 days and 14 days after randomization

    Time frame: Part B: Day 1-Day 15

Study contacts

Contact information is provided by the study sponsor or research team.

Lily Shi

CONTACT

[email protected]

+86 13381070876

Sponsors and collaborators

Lead sponsor

Beijing Sungen Biomedical Technology Co., Ltd

Industry

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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