Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06577558
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Efficacy and Safety of SR1375 in Adult Patients With CAP
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAP
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
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 1111 ratio to receive SR1375 03mg 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 hisher condition by investigator After completion of double-blind treatment period subjects will continue to complete the safety follow-up for 14 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None