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

NCT07803965 | Not Yet Recruiting Phase 2

• 2 other identifiers: SGC001-202CTR20263032
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 15

Brief 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. 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

Keywords

SGC001; Predicted Severe Acute Pancreatitis; Acute Pancreatitis

Outcome Measures

Primary Outcomes (2)

• 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.

  Part A Safety: Day 0- Day 85

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

  Part B: Day 1-Day 15

Secondary Outcomes (1)

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

  Part B: Day 1-Day 15

Study Arms (2)

SGC001 Injection

EXPERIMENTAL

Drug: SGC001 injection

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

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

Placebo

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

SGC001 Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Sungen Biomedical Technology Co., Ltd: lead

Study Sites (15)

West China Hospital, Sichuan University

Chengdu, China

Location

The Affiliated Hospital of Guizhou Medical University

Guizhou, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, China

Location

The Second Affiliated Hospital of Anhui Medical University

Hefei, China

Location

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, China

Location

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

Nanjing, China

Location

Li Huili Hospital, Ningbo Medical Center

Ningbo, China

Location

Shanghai General Hospital

Shanghai, China

Location

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

Shenyang, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, China

Location

Renmin Hospital of Wuhan University

Wuhan, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, China

Location

Zhongshan Hospital, Xiamen University

Xiamen, China

Location

Zibo Central Hospital

Zibo, China

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Central Study Contacts

Lily Shi

CONTACT

+86 13381070876; liping.shi@hotgen.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: September 4, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: September 4, 2026

Record last verified: 2026-08

Locations

CN (15)