Efficacy and Safety of SR1375 in Adult Patients With CAP (CAP)

July 7, 2025 updated by: Shanghai SIMR Biotechnology Co., Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Anhui
      • Fuyang, Anhui, China, 236001
        • Recruiting
        • Fuyang People's Hospital
    • Beijing
      • Beijing, Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
    • Fujian
      • Zhangzhou, Fujian, China, 363000
        • Recruiting
        • Zhangzhou Hospital
    • Guangdong
      • Gaozhou, Guangdong, China, 525200
        • Recruiting
        • Gaozhou People's Hospital
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • The First Affiliated Hospital of Sun Yat-sen University
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • The Third Affiliated Hospital of Southern Medical University
      • Guangzhou, Guangdong, China, 515399
        • Recruiting
        • Nanfang Hospital
      • Shantou, Guangdong, China, 515041
        • Recruiting
        • the First Affiliated Hospital of Shantou University Medical College
    • Guangxi
      • Yulin, Guangxi, China, 537000
        • Recruiting
        • Yulin First People's Hospital
    • Hebei
      • Shijiazhuang, Hebei, China, 050023
        • Recruiting
        • The First Hospital of Hebei Medical University
    • Heilongjiang
      • Daqing, Heilongjiang, China, 163000
        • Recruiting
        • Daqing People's Hospital
      • Daqing, Heilongjiang, China, 163000
        • Recruiting
        • Daqing Longnan Hospital
    • Henan
      • Shangqiu, Henan, China, 476100
        • Recruiting
        • Shangqiu People's Hospital
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Henan Provincial People's Hospital
    • Hunan
      • Yueyang, Hunan, China, 414000
        • Recruiting
        • Yueyang Central Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • Withdrawn
        • Nanjing First Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • Jiangxi Provincial People's Hospital
    • Jilin
      • Yanbian, Jilin, China, 133000
        • Withdrawn
        • Yanbian University Affiliated Hospital
    • Liaoning
      • Dalian, Liaoning, China, 116021
        • Recruiting
        • The Second Hospital of Dalian Medical University
      • Dalian, Liaoning, China, 116021
        • Recruiting
        • Dalian Central Hospital
    • Shandong
      • Weifang, Shandong, China, 261041
        • Recruiting
        • Weifang Second People's Hospital
      • Zibo, Shandong, China, 255100
        • Recruiting
        • Zibo Municipal Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Zhongshan hospital
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Shanghai Pulmonary Hospital
      • Shanghai, Shanghai, China, 200335
        • Recruiting
        • Shanghai Tongren Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
          • Dan Liu, Doctor
      • Chengdu, Sichuan, China, 610500
        • Recruiting
        • The First Affiliated Hospital of Chengdu Medical College
    • Zhejiang
      • Lishui, Zhejiang, China, 323000
        • Recruiting
        • Lishui Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SR1375 capsule 3mg
SR1375 capsule 3mg quaque die(QD) orally with CAP regular treatments for 8 weeks
Drug: SR1375 capsule 3mg+regular treatments
SR1375 capsule 3mg QD orally+CAP regular treatments
Other Names:
  • SR1375 capsule high dose+regular treatments
Experimental: SR1375 capsule 1mg
SR1375 capsule 1mg QD orally with CAP regular treatments for 8 weeks
Drug: SR1375 capsule 1mg+regular treatments
SR1375 capsule 1mg QD orally+CAP regular treatments
Other Names:
  • SR1375 capsule medium dose+regular treatments
Experimental: SR1375 capsule 0.3mg
SR1375 capsule 0.3mg QD orally with CAP regular treatments for 8 weeks
Drug: SR1375 capsule 0.3mg+regular treatments
SR1375 capsule 0.3mg QD orally+CAP regular treatments
Other Names:
  • SR1375 capsule low dose+regular treatments
Placebo Comparator: placebo capsule
Placebo capsule QD orally with CAP regular treatments for 8 weeks
Drug: Placebo capsule+regular treatments
Placebo capsule QD orally+CAP regular treatments

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
National Institute of Allergy and Infectious Diseases-Outcome Study (NIAID-OS) 8-point scale score
Time Frame: Up to Day 28
Change from baseline to Day 28 in NIAID-OS 8 scale score. NIAID-OS 8 scale ranges from 1 point (no hospitalization, no activity restrictions) to 8 points (death). The higher score means the worse outcome.
Up to Day 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects ≥ 2 points improvement in National Institute of Allergy and Infectious Diseases-Outcome Study (NIAID-OS) 8-point scale score
Time Frame: Up to Day 28
Subject proportion of ≥ 2 points improvement in NIAID-OS 8-point scale at Day 14 and Day 28
Up to Day 28
National Institute of Allergy and Infectious Diseases-Outcome Study (NIAID-OS) 8-point scale score
Time Frame: Up to Day 14
Change from baseline to Day 7 and Day 14 in NIAID-OS 8 scale score. NIAID-OS 8 scale ranges from 1 point (no hospitalization, no activity restrictions) to 8 points(death)，the higher score means the worse outcome.
Up to Day 14
All-cause mortality rate
Time Frame: Up to Day 56
The all-cause mortality rate at Day 28 and Day 56
Up to Day 56
Proportion of subjects with invasive mechanical ventilation, Extracorporeal Membrane Oxygenation(ECMO) or all-cause death.
Time Frame: Up to Day 56
Subjects proportions with invasive mechanical ventilation, ECMO or all-cause death at Day 28 and Day 56.
Up to Day 56
Proportion of subjects admitted in ICU or all-cause death
Time Frame: Up to Day 56
Proportion of subjects admitted in ICU or all-cause death at Day 28 and Day 56
Up to Day 56
Proportion of subjects ≤ 2 points in NIAID-OS 8-point scale
Time Frame: Up to Day 56
Proportion of subjects ≤ 2 points in NIAID-OS 8-point scale at Day 28 and Day 56
Up to Day 56
Survival days without invasive mechanical ventilation or ECMO
Time Frame: Up to Day 56
Survival days without invasive mechanical ventilation or ECMO within 28 and 56 days.
Up to Day 56
Survival days without ICU admission
Time Frame: Up to Day 56
Survival days without ICU admission within 28 and 56 days
Up to Day 56
Days of hospitalization
Time Frame: Up to Day 56
Days of hospitalization within 28 and 56 days
Up to Day 56
All-cause readmission rate
Time Frame: Up to Day 56
All-cause readmission rate within 56 days
Up to Day 56
Readmission rate due to pneumonia
Time Frame: Up to Day 56
Readmission rate due to pneumonia within 56 days
Up to Day 56
Partial Pressure of Oxygen(PaO2)/Fraction of Inspiration Oxygen(FiO2)
Time Frame: Up to Day 28
Change from baseline to Day 7 and Day 28 in PaO2/FiO2.
Up to Day 28

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The item short from health survey (SF-36) score
Time Frame: Up to Day 56
Change from baseline to Day 28 and Day 56 in SF-36 score. SF-36 scores range from 0 to 100 and the higher score means the better condition.
Up to Day 56
Adverse events and serious adverse events
Time Frame: Up to Day 70
AE and SAE occurence and severity during the study
Up to Day 70
Pharmacokinetic (PK) parameter Cmax
Time Frame: Up to Day 56
Maximum plasma concentration (Cmax) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
Up to Day 56
PK parameter Tmax
Time Frame: Up to Day 56
Time to maximum concentration (Tmax) will be calculated by PhoenixWinNonlin software (V8.0 or higher) .
Up to Day 56
PK parameter AUC0-t
Time Frame: Up to Day 56
Area under the concentration-time curve from 0 to the collection time t (AUC0-t) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
Up to Day 56
PK parameter t1/2
Time Frame: Up to Day 56
Half-Life (t1/2) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
Up to Day 56
PK parameter Vd/F
Time Frame: Up to Day 56
Apparent volume of distribution (Vd/F) will be calculated by PhoenixWinNonlin software (V8.0 or higher).
Up to Day 56
Pharmacodynamic (PD) parameter lipoprotein associated phospholipase A2 (Lp-PLA2) activity
Time Frame: Up to Day 56
PD parameter Lp-PLA2 activity will be tested in central laboratory.
Up to Day 56

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai SIMR Biotechnology Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Weimin Li, MD, West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SR1375-204

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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