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RECRUITING
NCT06577558
PHASE2

Efficacy and Safety of SR1375 in Adult Patients With CAP

Sponsor: Shanghai SIMR Biotechnology Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a phase 2 study to evaluate the efficacy and safety of SR1375 in hospitalized adult patients with CAP. Patients will receive SR1375 or placebo for 8 weeks. The study duration for each patient is up to 10 weeks.

Official title: A Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of SR1375 in Hospitalized Adult Patients With Community-acquired Pneumonia

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2024-09-10

Completion Date

2025-10-30

Last Updated

2025-07-09

Healthy Volunteers

No

Interventions

DRUG

SR1375 capsule 3mg+regular treatments

SR1375 capsule 3mg QD orally+CAP regular treatments

DRUG

SR1375 capsule 1mg+regular treatments

SR1375 capsule 1mg QD orally+CAP regular treatments

DRUG

SR1375 capsule 0.3mg+regular treatments

SR1375 capsule 0.3mg QD orally+CAP regular treatments

DRUG

Placebo capsule+regular treatments

Placebo capsule QD orally+CAP regular treatments

Locations (29)

Fuyang People's Hospital

Fuyang, Anhui, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

Zhangzhou Hospital

Zhangzhou, Fujian, China

Gaozhou People's Hospital

Gaozhou, Guangdong, China

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

The Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, China

Nanfang Hospital

Guangzhou, Guangdong, China

The First Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, China

Yulin First People's Hospital

Yulin, Guangxi, China

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Daqing Longnan Hospital

Daqing, Heilongjiang, China

Daqing People's Hospital

Daqing, Heilongjiang, China

Shangqiu People's Hospital

Shangqiu, Henan, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Yueyang Central Hospital

Yueyang, Hunan, China

Nanjing First Hospital

Nanjing, Jiangsu, China

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Yanbian University Affiliated Hospital

Yanbian, Jilin, China

Dalian Central Hospital

Dalian, Liaoning, China

The Second Hospital of Dalian Medical University

Dalian, Liaoning, China

Weifang Second People's Hospital

Weifang, Shandong, China

Zibo Municipal Hospital

Zibo, Shandong, China

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Shanghai Tongren Hospital

Shanghai, Shanghai Municipality, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

The First Affiliated Hospital of Chengdu Medical College

Chengdu, Sichuan, China

Lishui Central Hospital

Lishui, Zhejiang, China