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:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT05065359
Brief Summary:
This study is a randomized, placebo-controlled, multiple-ascending dose study in healthy Japanese and Caucasian subjects.
Detailed Description:
This study is a randomized, placebo-controlled, multiple-ascending dose study in healthy Japanese and Caucasian subjects. Two dose levels of rodatristat ethyl, 300 mg twice daily (BID) and 600 mg BID multiple doses (with a single dose lead in), will be explored in an ascending dose fashion with a safety review in between (Figure 1 below). Approximately 48 subjects will be enrolled in 4 cohorts.
Study:
NCT05065359
Study Brief:
Protocol Section:
NCT05065359