Efficacy and Safety of SR1375 in Adult Patients With CAP

NCT06577558 | Recruiting Phase 2

• 1 other identifier: SR1375-204
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 29

Brief 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.

Conditions

Community-acquired Pneumonia

Keywords

Community acquired Pneumonia; SR1375

Outcome Measures

Primary Outcomes (1)

• National Institute of Allergy and Infectious Diseases-Outcome Study (NIAID-OS) 8-point scale score

  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 Outcomes (12)

• Proportion of subjects ≥ 2 points improvement in National Institute of Allergy and Infectious Diseases-Outcome Study (NIAID-OS) 8-point scale score

  Up to Day 28

• National Institute of Allergy and Infectious Diseases-Outcome Study (NIAID-OS) 8-point scale score

  Up to Day 14

• All-cause mortality rate

  Up to Day 56

• Proportion of subjects with invasive mechanical ventilation, Extracorporeal Membrane Oxygenation(ECMO) or all-cause death.

  Up to Day 56

• Partial Pressure of Oxygen(PaO2)/Fraction of Inspiration Oxygen(FiO2)

  Up to Day 28

Other Outcomes (8)

• The item short from health survey (SF-36) score

  Up to Day 56

• Adverse events and serious adverse events

  Up to Day 70

• Pharmacokinetic (PK) parameter Cmax

  Up to Day 56

Study Arms (4)

SR1375 capsule 3mg

EXPERIMENTAL

SR1375 capsule 3mg quaque die(QD) orally with CAP regular treatments for 8 weeks

Drug: SR1375 capsule 3mg+regular treatments

SR1375 capsule 1mg

EXPERIMENTAL

SR1375 capsule 1mg QD orally with CAP regular treatments for 8 weeks

Drug: SR1375 capsule 1mg+regular treatments

SR1375 capsule 0.3mg

EXPERIMENTAL

SR1375 capsule 0.3mg QD orally with CAP regular treatments for 8 weeks

Drug: SR1375 capsule 0.3mg+regular treatments

placebo capsule

PLACEBO COMPARATOR

Placebo capsule QD orally with CAP regular treatments for 8 weeks

Drug: Placebo capsule+regular treatments

Interventions

SR1375 capsule 3mg+regular treatments DRUG

SR1375 capsule 3mg QD orally+CAP regular treatments

Also known as: SR1375 capsule high dose+regular treatments

SR1375 capsule 3mg

SR1375 capsule 1mg+regular treatments DRUG

SR1375 capsule 1mg QD orally+CAP regular treatments

Also known as: SR1375 capsule medium dose+regular treatments

SR1375 capsule 1mg

SR1375 capsule 0.3mg+regular treatments DRUG

SR1375 capsule 0.3mg QD orally+CAP regular treatments

Also known as: SR1375 capsule low dose+regular treatments

SR1375 capsule 0.3mg

Placebo capsule+regular treatments DRUG

Placebo capsule QD orally+CAP regular treatments

placebo capsule

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai SIMR Biotechnology Co., Ltd.: lead

Study Sites (29)

Fuyang People's Hospital

Fuyang, Anhui, 236001, China

RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Zhangzhou Hospital

Zhangzhou, Fujian, 363000, China

RECRUITING

Gaozhou People's Hospital

Gaozhou, Guangdong, 525200, China

RECRUITING

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

The Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, 510630, China

RECRUITING

Nanfang Hospital

Guangzhou, Guangdong, 515399, China

RECRUITING

The First Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, 515041, China

RECRUITING

Yulin First People's Hospital

Yulin, Guangxi, 537000, China

RECRUITING

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050023, China

RECRUITING

Daqing Longnan Hospital

Daqing, Heilongjiang, 163000, China

RECRUITING

Daqing People's Hospital

Daqing, Heilongjiang, 163000, China

RECRUITING

Shangqiu People's Hospital

Shangqiu, Henan, 476100, China

RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

Yueyang Central Hospital

Yueyang, Hunan, 414000, China

RECRUITING

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

WITHDRAWN

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, 330006, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

Yanbian University Affiliated Hospital

Yanbian, Jilin, 133000, China

WITHDRAWN

Dalian Central Hospital

Dalian, Liaoning, 116021, China

RECRUITING

The Second Hospital of Dalian Medical University

Dalian, Liaoning, 116021, China

RECRUITING

Weifang Second People's Hospital

Weifang, Shandong, 261041, China

RECRUITING

Zibo Municipal Hospital

Zibo, Shandong, 255100, China

RECRUITING

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Shanghai Tongren Hospital

Shanghai, Shanghai Municipality, 200335, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

The First Affiliated Hospital of Chengdu Medical College

Chengdu, Sichuan, 610500, China

RECRUITING

Lishui Central Hospital

Lishui, Zhejiang, 323000, China

RECRUITING

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Weimin Li, MD

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wang, PhD

CONTACT

(086)021-68161783; fwang@simrbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 29, 2024
• Study Start: September 10, 2024
• Primary Completion: October 15, 2025
• Study Completion: October 30, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (29)