Acute PancreatitisPhase 2NCT07803965
Study of SGC001 Injection for Predicted Severe Acute Pancreatitis to Assess Safety, Tolerability and Preliminary Efficacy
A Phase 2 study testing SGC001 injection in people with Acute Pancreatitis, run by Beijing Sungen Biomedical Technology Co., Ltd at 15 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- SGC001 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 15 sitesChina
- Study dates
- 30 Sep 2026to Jan 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
China15 sites, 15 recruiting
- Not yet recruiting
West China Hospital, Sichuan University
Chengdu
- Not yet recruiting
The Affiliated Hospital of Guizhou Medical University
Guizhou
- Not yet recruiting
Zhejiang Provincial People's Hospital
Hangzhou
- Not yet recruiting
The Second Affiliated Hospital of Anhui Medical University
Hefei
- Not yet recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang
- Recruiting
General Hospital of the Eastern Theater Command of the Chinese People's Liberation Army
Nanjing
- Not yet recruiting
Li Huili Hospital, Ningbo Medical Center
Ningbo
- Not yet recruiting
Shanghai General Hospital
Shanghai
- Not yet recruiting
General Hospital of Northern Theater Command of the Chinese People's Liberation Army
Shenyang
- Not yet recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang
- Not yet recruiting
Renmin Hospital of Wuhan University
Wuhan
- Not yet recruiting
The First Affiliated Hospital of Xiamen University
Xiamen
- Not yet recruiting
Zhongshan Hospital, Xiamen University
Xiamen
- Not yet recruiting
Zibo Central Hospital
Zibo
About this study
Official 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.
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.
- Conditions
- Acute Pancreatitis
- Being tested
- SGC001 injection, Placebo
- Keywords
- SGC001, Predicted Severe Acute Pancreatitis, Acute Pancreatitis
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGC001 injectionDrug
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
PlaceboDrug
Specification: 0mg(10mL)per vial Dosage Administration: 0mg as a single intravenous infusion Infusion Duration:60±10minutes
| Study group | Role | What they receive |
|---|---|---|
| SGC001 Injection | Experimental | Not described Receives: Drug: SGC001 injection |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Safety Adverse Event (AE)
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.
Measured: Part A Safety: Day 0- Day 85
Part B: Days alive free of organ failure within 14 days post-randomization
Measured: Part B: Day 1-Day 15
Secondary outcomes (1)
Part B: Days alive without SIRS within 7 days and 14 days after randomization
Measured: Part B: Day 1-Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start30 Sep 2026
- Primary completionNov 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Sungen Biomedical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803965
- Sponsor's protocol ID
- SGC001-202
- Other IDs
- CTR20263032
- Status last verified
- Oct 2026
- First submitted
- 25 Aug 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No