Study of SGC001 Injection for Predicted Severe Acute Pancreatitis to Assess Safety, Tolerability and Preliminary Efficacy
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Placebo: Specification: 0mg(10mL)per vial Dosage Administration: 0mg as a single intravenous infusion Infusion Duration:60±10minutes
Study 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.
Eligibility
Primary outcome measure(s)
- Part A: Safety Adverse Event (AE) — 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 B: Days alive free of organ failure within 14 days post-randomization — Part B: Day 1-Day 15
Trial sites (15)
| Facility | City | Region | Status |
|---|---|---|---|
| West China Hospital, Sichuan University | Chengdu | China | Not Yet Recruiting |
| The Affiliated Hospital of Guizhou Medical University | Guizhou | China | Not Yet Recruiting |
| Zhejiang Provincial People's Hospital | Hangzhou | China | Not Yet Recruiting |
| The Second Affiliated Hospital of Anhui Medical University | Hefei | China | Not Yet Recruiting |
| The First Affiliated Hospital of Henan University of Science and Technology | Luoyang | China | Not Yet Recruiting |
| The First Affiliated Hospital of Nanchang University | Nanchang | China | Not Yet Recruiting |
| General Hospital of the Eastern Theater Command of the Chinese People's Liberation Army | Nanjing | China | Recruiting |
| Li Huili Hospital, Ningbo Medical Center | Ningbo | China | Not Yet Recruiting |
| Shanghai General Hospital | Shanghai | China | Not Yet Recruiting |
| General Hospital of Northern Theater Command of the Chinese People's Liberation Army | Shenyang | China | Not Yet Recruiting |
| The Second Hospital of Hebei Medical University | Shijiazhuang | China | Not Yet Recruiting |
| Renmin Hospital of Wuhan University | Wuhan | China | Not Yet Recruiting |
| The First Affiliated Hospital of Xiamen University | Xiamen | China | Not Yet Recruiting |
| Zhongshan Hospital, Xiamen University | Xiamen | China | Not Yet Recruiting |
| Zibo Central Hospital | Zibo | China | Not Yet Recruiting |
More Beijing Sungen Biomedical Technology Co., Ltd trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07803965 on ClinicalTrials.gov ↗ ← All trials in China