Usun Bio

Primary objective: To evaluate the safety of TISA-818-Inj in patients with acute respiratory distress syndrome (ARDS). Secondary objectives To evaluate the preliminary efficacy of TISA-818-Inj in patients with ARDS; To evaluate the population pharmacokinetic (Pop PK) characteristics of TISA-818-Inj in patients with ARDS. To evaluate the PK characteristics of TISA-818 in bronchoalveolar lavage fluid.

Primary objectives: (1) To evaluate the safety and tolerability of rectal montelukast sodium gel in patients with RARI. (2) To evaluate the preliminary efficacy of rectal montelukast sodium gel in patients with RARI based on the primary efficacy endpoint [change from baseline in the severity of rectal injury symptoms at each visit using the Radiation Therapy Oncology Group (RTOG)/European Organization for Research and Treatment of Cancer (EORTC) acute radiation injury grading criteria]. Secondary objectives: (1) To evaluate the PK characteristics and dose-exposure-effect relationship (if applicable) of rectal montelukast sodium gel in patients with RARI; (2) To evaluate the preliminary efficacy of rectal montelukast sodium gel in patients with RARI based on other efficacy endpoints.

The primary objective was to evaluate the tolerability and safety of single and multiple rectal administrations of montelukast sodium gel in healthy subjects, and the secondary objective was to evaluate the pharmacokinetic (PK) characteristics of single and multiple rectal administrations of montelukast sodium gel in healthy subjects.