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Clinical Trial Summary

The purpose of this study is to to evaluate the effect of ASP0367 on improvement of aerobic capacity relative to placebo, as well as evaluate the safety and tolerability of ASP0367 relative to placebo. This study will also evaluate the effect of ASP0367 on improvement of other aerobic capacity parameters relative to placebo, as well as evaluate the effect of ASP0367 on improvement of functional capacity relative to placebo.


Clinical Trial Description

The study will consist of a screening period (up to 27 days [approximately 4 weeks]), treatment period (up to 44 days [6 weeks]) and follow-up period (7 days [1 week]). The study will be completed with an end-of-study visit (ESV). The ESV will take place 7 days (1 week) after the end-of-treatment on day 44 (week 6) or 7 days (1 week) after early discontinuation from the study. The anticipated total duration of the study for each participant, including screening and follow-up, is approximately 75 days (11 week). ;


Study Design


NCT number NCT04855201
Study type Interventional
Source Astellas Pharma Inc
Contact Astellas Pharma Global Development, Inc.
Phone 800-888-7704
Email [email protected]
Status Not yet recruiting
Phase Phase 1
Start date April 30, 2021
Completion date June 30, 2022