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

Status: Recruiting
Location: See all (29) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• The subject or their legally acceptable representative (LAR) has voluntarily signed the informed consent form (ICF) prior to any study-related procedures, and the subject is willing and able to comply with all study requirements, restrictions, and procedures. If consent is provided by an LAR for a subject with limited or no capacity to consent, re-consenting may be performed if the subject regains capacity.

• Aged 18 to 85 years.

• Diagnosis of CAP

• Prior to screening, the subject has been receiving standard-of-care treatment for pneumonia in a medical institution, including at least 3 days of intravenous (IV) anti-infective therapy, with no clinical improvement.

• Chest CT showing multi-lobar infiltrates, and for subjects not receiving invasive mechanical ventilation, an oxygenation index (PaO2/FiO2 ratio) between 100 and 300 mmHg.

• Expected to require continued hospitalization for at least 7 days from the time of signing the ICF.

• Baseline NIAID-OS 8-point scale score of 5 points and transcutaneous oxygen saturation ≤ 93% without oxygen inhalation, 6 points or 7points. (5 points refer to hospitalization with oxygen therapy; 6 points refer to hospitalization with high flow oxygen therapy or non-invasive mechanical ventilation. 7 points refer to hospitalization with invasive mechanical ventilation).High oxygen flow refers to ≥ 4 L/min.)

• With ≥ 1 high risk factors including chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, type 2 diabetes, chronic kidney disease, coronary heart disease, age ≥ 65 years, moderate obesity (body mass index\>32.5kg/m2), etc.

• Participants of women of childbearing potential(WOCBP) and male participants with WOCBP partners must agree to use one or more effective contraceptive methods during the treatment period and until 90 days after the last administration.

Locations
Other Locations
China
Peking University Third Hospital
RECRUITING
Beijing
The First Affiliated Hospital of Chengdu Medical College
RECRUITING
Chengdu
West China Hospital of Sichuan University
RECRUITING
Chengdu
Dalian Central Hospital
RECRUITING
Dalian
The Second Hospital of Dalian Medical University
RECRUITING
Dalian
Daqing Longnan Hospital
RECRUITING
Daqing
Daqing People's Hospital
RECRUITING
Daqing
Fuyang People's Hospital
RECRUITING
Fuyang
Gaozhou People's Hospital
RECRUITING
Gaozhou
Nanfang Hospital
RECRUITING
Guangzhou
The First Affiliated Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
The Third Affiliated Hospital of Southern Medical University
RECRUITING
Guangzhou
Lishui Central Hospital
RECRUITING
Lishui
Jiangxi Provincial People's Hospital
RECRUITING
Nanchang
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Nanjing First Hospital
WITHDRAWN
Nanjing
Shanghai Pulmonary Hospital
RECRUITING
Shanghai
Shanghai Tongren Hospital
RECRUITING
Shanghai
Zhongshan Hospital
RECRUITING
Shanghai
Shangqiu People's Hospital
RECRUITING
Shangqiu
The First Affiliated Hospital of Shantou University Medical College
RECRUITING
Shantou
The First Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Weifang Second People's Hospital
RECRUITING
Weifang
Yanbian University Affiliated Hospital
WITHDRAWN
Yanbian
Yueyang Central Hospital
RECRUITING
Yueyang
Yulin First People's Hospital
RECRUITING
Yulin
Zhangzhou Hospital
RECRUITING
Zhangzhou
Henan Provincial People's Hospital
RECRUITING
Zhengzhou
Zibo Municipal Hospital
RECRUITING
Zibo
Contact Information
Primary
Wang, PhD
fwang@simrbio.com
(086)021-68161783
Time Frame
Start Date: 2024-09-10
Estimated Completion Date: 2025-10-30
Participants
Target number of participants: 240
Treatments
Experimental: SR1375 capsule 3mg
SR1375 capsule 3mg quaque die(QD) orally with CAP regular treatments for 8 weeks
Experimental: SR1375 capsule 1mg
SR1375 capsule 1mg QD orally with CAP regular treatments for 8 weeks
Experimental: SR1375 capsule 0.3mg
SR1375 capsule 0.3mg QD orally with CAP regular treatments for 8 weeks
Placebo_comparator: placebo capsule
Placebo capsule QD orally with CAP regular treatments for 8 weeks
Related Therapeutic Areas
Sponsors
Leads: Shanghai SIMR Biotechnology Co., Ltd.

This content was sourced from clinicaltrials.gov