Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07319351
Brief Summary:
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.
Study:
NCT07319351
Study Brief:
Protocol Section:
NCT07319351