Efficacy and Safety of SR1375 in Adult Patients With CAP

Last updated: July 7, 2025
Sponsor: Shanghai SIMR Biotechnology Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Pneumonia (Pediatric)

Pneumonia

Treatment

Placebo capsule+regular treatments

SR1375 capsule 3mg+regular treatments

SR1375 capsule 1mg+regular treatments

Clinical Study ID

NCT06577558
SR1375-204
  • Ages 18-85
  • All Genders

Study 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 Criteria

Inclusion

Key Inclusion Criteria:

  • The subject or their legally acceptable representative (LAR) has voluntarily signedthe informed consent form (ICF) prior to any study-related procedures, and thesubject is willing and able to comply with all study requirements, restrictions, andprocedures. If consent is provided by an LAR for a subject with limited or nocapacity 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 forpneumonia 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 invasivemechanical ventilation, an oxygenation index (PaO2/FiO2 ratio) between 100 and 300mmHg.

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

  • Baseline NIAID-OS 8-point scale score of 5 points and transcutaneous oxygensaturation ≤ 93% without oxygen inhalation, 6 points or 7points. (5 points refer tohospitalization with oxygen therapy; 6 points refer to hospitalization with highflow oxygen therapy or non-invasive mechanical ventilation. 7 points refer tohospitalization with invasive mechanical ventilation).High oxygen flow refers to ≥ 4L/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 withWOCBP partners must agree to use one or more effective contraceptive methods duringthe treatment period and until 90 days after the last administration.

Exclusion

Key Exclusion Criteria:

  • Patients who are currently receiving or are expected to require ECMO treatmentwithin 24 hours.

  • Presence of active tuberculosis (TB) or severe asthma.

  • History of unstable angina or acute myocardial infarction within 3 months prior toscreening, or stroke within 4 weeks prior to screening.

  • Received chemotherapy and/or immunotherapy for a malignant tumor within 4 weeksprior to randomization, or are planned to receive such treatment during the studyperiod; presence of a hematological malignancy not in complete remission; or a lungtumor with concurrent obstructive pneumonia.

  • Presence of any concomitant disease that is expected to result in death within 12weeks after randomization.

  • Prior use of JAK inhibitors (e.g., Baricitinib), interleukin receptor inhibitors (e.g., Tocilizumab), or any investigational drug in another clinical trial, wherethe last dose was administered less than 5 half-lives before the first dose of thestudy 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 EpidemiologyCollaboration [CKD-EPI] formula); however, patients undergoing dialysis may beincluded upon the investigator's assessment of their suitability for the trial.

  • Presence of clinically significant abnormalities on ECG that may seriously affectsubject safety, e.g., QTcF > 480 ms.

  • Female subjects who are pregnant, lactating, or have a positive serum β-HCGpregnancy test.

  • Presence of any severe systemic disease or clinical condition that, in theinvestigator's judgment, makes the subject unsuitable for participation in thisstudy.

Study Design

Total Participants: 240
Treatment Group(s): 4
Primary Treatment: Placebo capsule+regular treatments
Phase: 2
Study Start date:
September 10, 2024
Estimated Completion Date:
October 30, 2025

Study Description

This is a randomized, double-blind and placebo-controlled phase 2 study comparing SR1375 with placebo in adult patients with CAP. It consists of a screening period, a double-blind treatment period, and a post-treatment safety follow-up period. Baseline NIAID-OS 8-point scale score will be checked for eligibility. Around 240 eligible subjects will be recruited and randomized into four arms at 1:1:1:1 ratio to receive SR1375 0.3mg, SR1375 1mg, SR1375 3mg or placebo orally daily for 56 days. Subjects, investigators, all clinical study site staffs, and the Sponsor will remain blinded to treatment assignment during the study. Subjects will receive regular treatments as per his/her condition by investigator. After completion of double-blind treatment period, subjects will continue to complete the safety follow-up for 14 days.

Connect with a study center

  • Fuyang People's Hospital

    Fuyang, Anhui 236001
    China

    Active - Recruiting

  • Peking University Third Hospital

    Beijing, Beijing 100191
    China

    Active - Recruiting

  • Zhangzhou Hospital

    Zhangzhou, Fujian 363000
    China

    Active - Recruiting

  • Gaozhou People's Hospital

    Gaozhou, Guangdong 525200
    China

    Active - Recruiting

  • Nanfang Hospital

    Guangzhou, Guangdong 515399
    China

    Active - Recruiting

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong 510080
    China

    Active - Recruiting

  • The Third Affiliated Hospital of Southern Medical University

    Guangzhou, Guangdong 510630
    China

    Active - Recruiting

  • The First Affiliated Hospital of Shantou University Medical College

    Shantou, Guangdong 515041
    China

    Active - Recruiting

  • Yulin First People's Hospital

    Yulin, Guangxi 537000
    China

    Active - Recruiting

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050023
    China

    Active - Recruiting

  • Daqing Longnan Hospital

    Daqing, Heilongjiang 163000
    China

    Active - Recruiting

  • Daqing People's Hospital

    Daqing, Heilongjiang 163000
    China

    Active - Recruiting

  • Shangqiu People's Hospital

    Shangqiu, Henan 476100
    China

    Active - Recruiting

  • Henan Provincial People's Hospital

    Zhengzhou, Henan 450003
    China

    Active - Recruiting

  • Yueyang Central Hospital

    Yueyang, Hunan 414000
    China

    Active - Recruiting

  • Nanjing First Hospital

    Nanjing, Jiangsu 210006
    China

    Site Not Available

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi 330006
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Active - Recruiting

  • Yanbian University Affiliated Hospital

    Yanbian, Jilin 133000
    China

    Site Not Available

  • Dalian Central Hospital

    Dalian, Liaoning 116021
    China

    Active - Recruiting

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning 116021
    China

    Active - Recruiting

  • Weifang Second People's Hospital

    Weifang, Shandong 261041
    China

    Active - Recruiting

  • Zibo Municipal Hospital

    Zibo, Shandong 255100
    China

    Active - Recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai 200433
    China

    Active - Recruiting

  • Shanghai Tongren Hospital

    Shanghai, Shanghai 200335
    China

    Active - Recruiting

  • Zhongshan Hospital

    Shanghai, Shanghai 200032
    China

    Active - Recruiting

  • The First Affiliated Hospital of Chengdu Medical College

    Chengdu, Sichuan 610500
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

  • Lishui Central Hospital

    Lishui, Zhejiang 323000
    China

    Active - Recruiting

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