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Can a single infusion prevent organ failure in severe pancreatitis?

NCT ID NCT07803965

Disease control Sponsor: Beijing Sungen Biomedical Technology Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This trial tests an experimental drug called SGC001 in people who are likely to develop severe acute pancreatitis, a painful inflammation of the pancreas that can lead to organ failure. Participants receive either SGC001 or a placebo as a single intravenous infusion alongside standard care. The study checks the drug's safety, how the body processes it, and whether it helps keep organs working. The trial has two parts: the first focuses on finding a safe dose, and the second looks at whether the drug reduces days with organ failure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SGC001 injection, an experimental drug given as a single intravenous infusion
What this could lead to
If it works, SGC001 could become an add-on treatment to prevent organ failure in people with predicted severe acute pancreatitis, reducing the need for intensive care.
What could go wrong
This is an early phase IIa trial with a small number of participants, so the drug may not prove effective or safe. The main risks are side effects from the infusion, and the results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 129 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

acute pancreatitis pancreatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute pancreatitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • General Hospital of Northern Theater Command of the Chinese People's Liberation Army

    Shenyang, China

  • General Hospital of the Eastern Theater Command of the Chinese People's Liberation Army

    Nanjing, China

  • Li Huili Hospital, Ningbo Medical Center

    Ningbo, China

  • Renmin Hospital of Wuhan University

    Wuhan, China

  • Shanghai General Hospital

    Shanghai, China

  • The Affiliated Hospital of Guizhou Medical University

    Guizhou, China

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, China

  • The First Affiliated Hospital of Xiamen University

    Xiamen, China

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, China

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, China

  • West China Hospital, Sichuan University

    Chengdu, China

  • Zhejiang Provincial People's Hospital

    Hangzhou, China

  • Zhongshan Hospital, Xiamen University

    Xiamen, China

  • Zibo Central Hospital

    Zibo, China

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