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Safety and Preliminary Efficacy of TISA-818 Injection in Patients With Acute Respiratory Distress Syndrome
This is a randomized, double-blind, placebo-controlled Phase II clinical study of TISA-818-Inj in patients with ARDS to evaluate the safety, preliminary efficacy, and population PK (Pop PK) profile of TISA-818-Inj in adult ARDS patients. Totally 60 subjects with ARDS are planned to be included in this study. Subjects will be assigned to the 6 mg twice daily (BID) TISA-818-Inj group, 12 mg once daily (QD) TISA-818-Inj group, or the placebo control group in a 1:1:1 ratio using a stratified block randomization method. This study includes a screening period (Day -3 to Day -1), a treatment period (Day 1 to Day 14),a short-term follow-up period (Day 15 to Day 60) and a long-term follow-up period (Day 61 to Day 180). Consenting subjects will be screened for eligibility, according to study-specific inclusion/exclusion criteria.
Details
| Lead sponsor | EnliTISA (Shanghai) Pharmaceutical Co., Ltd. |
|---|---|
| Phase | PHASE2 |
| Status | COMPLETED |
| Enrolment | 57 |
| Start date | Thu Oct 12 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Mon Sep 15 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Acute Respiratory Distress Syndrome (ARDS)
Interventions
- TISA-818-Inj
- TISA-818-Inj
- Placebo
Countries
China