Efficacy and Safety of SR1375 in Adult Patients With CAP
NCT Number: NCT06577558
Acronym: CAP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Community-acquired Pneumonia
Interventions: DRUG: SR1375 capsule 3mg+regular treatments|DRUG: SR1375 capsule 1mg+regular treatments|DRUG: SR1375 capsule 0.3mg+regular treatments|DRUG: Placebo capsule+regular treatments
Sponsor: Shanghai SIMR Biotechnology Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-28
Completion Date: 2025-10-10

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.

Primary Outcome Measures: 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 Outcome Measures: Proportion of subjects ≥ 2 points improvement in National Institute of Allergy and Infectious Diseases-Outcome Study (NIAID-OS) 8-point scale score, 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, 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, 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., Subjects proportions with invasive mechanical ventilation, ECMO or all-cause death at Day 28 and Day 56., Up to Day 56|Partial Pressure of Oxygen(PaO2)/Fraction of Inspiration Oxygen(FiO2), Change from baseline to Day 7, Day 28 and Day 56 in PaO2/FiO2., Up to Day 56|Proportion of subjects admitted in ICU or all-cause death, 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, 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, Survival days without invasive mechanical ventilation or ECMO within 28 and 56 days., Up to Day 56|Survival days without ICU admission, Survival days without ICU admission within 28 and 56 days, Up to Day 56|Days of hospitalization, Days of hospitalization within 28 and 56 days, Up to Day 56|All-cause readmission rate, All-cause readmission rate within 56 days, Up to Day 56|Readmission rate due to pneumonia, Readmission rate due to pneumonia within 56 days, Up to Day 56
Other Outcome Measures: The item short from health survey (SF-36) score, 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, AE and SAE occurence and severity during the study, Up to Day 70|Pharmacokinetic (PK) parameter Cmax, Maximum plasma concentration (Cmax) will be calculated by PhoenixWinNonlin software (V8.0 or higher)., Up to Day 56|PK parameter Tmax, Time to maximum concentration (Tmax) will be calculated by PhoenixWinNonlin software (V8.0 or higher) ., Up to Day 56|PK parameter AUC0-t, 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, Half-Life (t1/2) will be calculated by PhoenixWinNonlin software (V8.0 or higher)., Up to Day 56|PK parameter Vd/F, 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, PD parameter Lp-PLA2 activity will be tested in central laboratory., Up to Day 56