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NOT YET RECRUITING
NCT07803965
PHASE2

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

Sponsor: Beijing Sungen Biomedical Technology Co., Ltd

View on ClinicalTrials.gov

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

Interventions

DRUG

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

DRUG

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