Efficacy and Safety of SR1375 in Adult Patients With CAP
NCT ID: NCT06577558
Last Updated: 2025-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
240 participants
INTERVENTIONAL
2024-09-10
2025-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SR1375 capsule 3mg
SR1375 capsule 3mg quaque die(QD) orally with CAP regular treatments for 8 weeks
SR1375 capsule 3mg+regular treatments
SR1375 capsule 3mg QD orally+CAP regular treatments
SR1375 capsule 1mg
SR1375 capsule 1mg QD orally with CAP regular treatments for 8 weeks
SR1375 capsule 1mg+regular treatments
SR1375 capsule 1mg QD orally+CAP regular treatments
SR1375 capsule 0.3mg
SR1375 capsule 0.3mg QD orally with CAP regular treatments for 8 weeks
SR1375 capsule 0.3mg+regular treatments
SR1375 capsule 0.3mg QD orally+CAP regular treatments
placebo capsule
Placebo capsule QD orally with CAP regular treatments for 8 weeks
Placebo capsule+regular treatments
Placebo capsule QD orally+CAP regular treatments
Interventions
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SR1375 capsule 3mg+regular treatments
SR1375 capsule 3mg QD orally+CAP regular treatments
SR1375 capsule 1mg+regular treatments
SR1375 capsule 1mg QD orally+CAP regular treatments
SR1375 capsule 0.3mg+regular treatments
SR1375 capsule 0.3mg QD orally+CAP regular treatments
Placebo capsule+regular treatments
Placebo capsule QD orally+CAP regular treatments
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Presence of active tuberculosis (TB) or severe asthma.
* History of unstable angina or acute myocardial infarction within 3 months prior to screening, or stroke within 4 weeks prior to screening.
* Received chemotherapy and/or immunotherapy for a malignant tumor within 4 weeks prior to randomization, or are planned to receive such treatment during the study period; presence of a hematological malignancy not in complete remission; or a lung tumor with concurrent obstructive pneumonia.
* Presence of any concomitant disease that is expected to result in death within 12 weeks after randomization.
* Prior use of JAK inhibitors (e.g., Baricitinib), interleukin receptor inhibitors (e.g., Tocilizumab), or any investigational drug in another clinical trial, where the last dose was administered less than 5 half-lives before the first dose of the study drug in this trial.
* ALT) or AST \> 3 times the upper limit of normal (ULN).
* eGFR \< 30 mL/min/1.73 m² (calculated using the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula); however, patients undergoing dialysis may be included upon the investigator's assessment of their suitability for the trial.
* Presence of clinically significant abnormalities on ECG that may seriously affect subject safety, e.g., QTcF \> 480 ms.
* Female subjects who are pregnant, lactating, or have a positive serum β-HCG pregnancy test.
* Presence of any severe systemic disease or clinical condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study.
18 Years
85 Years
ALL
No
Sponsors
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Shanghai SIMR Biotechnology Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Weimin Li, MD
Role: PRINCIPAL_INVESTIGATOR
West China Hospital
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Dan Liu, Doctor
Role: primary
Other Identifiers
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SR1375-204
Identifier Type: -
Identifier Source: org_study_id
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