NCT06577558

Efficacy and Safety of SR1375 in Adult Patients With CAP

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Shanghai SIMR Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Community-acquired Pneumonia

Interventions

Type	Name	Description
DRUG	SR1375 capsule 3mg+regular treatments	SR1375 capsule 3mg QD orally+CAP regular treatments
DRUG	SR1375 capsule 1mg+regular treatments	SR1375 capsule 1mg QD orally+CAP regular treatments
DRUG	SR1375 capsule 0.3mg+regular treatments	SR1375 capsule 0.3mg QD orally+CAP regular treatments
DRUG	Placebo capsule+regular treatments	Placebo capsule QD orally+CAP regular treatments

Timeline

• Start date: 2024-09-10
• Primary completion: 2025-10-15
• Completion: 2025-10-30
• First posted: 2024-08-29
• Last updated: 2025-07-09

Locations

29 sites across 1 country: China