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

August 31, 2026 updated by: Beijing Sungen Biomedical Technology Co., Ltd

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
129

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Chengdu, China
        • West China Hospital, Sichuan University
      • Guizhou, China
        • The Affiliated Hospital of Guizhou Medical University
      • Hangzhou, China
        • Zhejiang Provincial People's Hospital
      • Hefei, China
        • The Second Affiliated Hospital of Anhui Medical University
      • Luoyang, China
        • The First Affiliated Hospital of Henan University of Science and Technology
      • Nanchang, China
        • The First Affiliated Hospital of Nanchang University
      • Nanjing, China
        • General Hospital of the Eastern Theater Command of the Chinese People's Liberation Army
      • Ningbo, China
        • Li Huili Hospital, Ningbo Medical Center
      • Shanghai, China
        • Shanghai General Hospital
      • Shenyang, China
        • General Hospital of Northern Theater Command of the Chinese People's Liberation Army
      • Shijiazhuang, China
        • The Second Hospital of Hebei Medical University
      • Wuhan, China
        • Renmin Hospital of Wuhan University
      • Xiamen, China
        • The First Affiliated Hospital of Xiamen University
      • Xiamen, China
        • Zhongshan Hospital, Xiamen University
      • Zibo, China
        • Zibo central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
Specification: 0mg(10mL)per vial Dosage Administration: 0mg as a single intravenous infusion Infusion Duration:60±10minutes
Experimental: SGC001 Injection
Drug: SGC001 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Part A Safety: Day 0- Day 85
Part B: Days alive free of organ failure within 14 days post-randomization
Time Frame: Part B: Day 1-Day 15
Part B: Day 1-Day 15

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Part B: Days alive without SIRS within 7 days and 14 days after randomization
Time Frame: Part B: Day 1-Day 15
Part B: Day 1-Day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Sungen Biomedical Technology Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SGC001-202
  • CTR20263032 (Registry Identifier: China Center for Drug Evaluation (CDE), NMPA)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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