Clinical Research Directory
Browse clinical research sites, groups, and studies.
Study of SGC001 Injection for Predicted Severe Acute Pancreatitis to Assess Safety, Tolerability and Preliminary Efficacy
Sponsor: Beijing Sungen Biomedical Technology Co., Ltd
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.
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.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
129
Start Date
2026-09
Completion Date
2028-01
Last Updated
2026-09-04
Healthy Volunteers
No
Conditions
Interventions
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
Locations (15)
West China Hospital, Sichuan University
Chengdu, China
The Affiliated Hospital of Guizhou Medical University
Guizhou, China
Zhejiang Provincial People's Hospital
Hangzhou, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, China
The First Affiliated Hospital of Nanchang University
Nanchang, 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
Shanghai General Hospital
Shanghai, China
General Hospital of Northern Theater Command of the Chinese People's Liberation Army
Shenyang, China
The Second Hospital of Hebei Medical University
Shijiazhuang, China
Renmin Hospital of Wuhan University
Wuhan, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
Zhongshan Hospital, Xiamen University
Xiamen, China
Zibo Central Hospital
Zibo, China