Efficacy and Safety of SR1375 in Adult Patients With CAP
ConditionCommunity-acquired Pneumonia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorShanghai SIMR Biotechnology Co., Ltd.
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- SR1375 capsule 3mg+regular treatments
- SR1375 capsule 1mg+regular treatments
- SR1375 capsule 0.3mg+regular treatments
- Placebo capsule+regular treatments
Treatment groups
240 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov