A Phase 3 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of L606 in Subjects With PAH

Summary

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Description

This single-arm, Phase 3, 2-part, open-label, multicenter study aims to demonstrate the safety and tolerability of repeated doses of L606 in patients with PAH switching from a stable Tyvaso dose. The current Phase 3 study will help determine the short-term and long-term safety and tolerability of L6...

This single-arm, Phase 3, 2-part, open-label, multicenter study aims to demonstrate the safety and tolerability of repeated doses of L606 in patients with PAH switching from a stable Tyvaso dose. The current Phase 3 study will help determine the short-term and long-term safety and tolerability of L606 in this patient population. The study will also evaluate the steady-state pharmacokinetics (PK) of L606 as compared to Tyvaso, effects on exercise ability (6-minute walk distance [6MWD] and Borg Dyspnea Score), quality of life (QoL), and treatment satisfaction with L606 in patients with PAH. Part 1 of the study is short-term (2-week) evaluation of L606 in patients with PAH. Part 2 of the study will continue to assess the long-term safety and efficacy of L606 in patients with PAH. Results of Part 1 and Part 2 of the study will be presented in separate clinical study reports and clinical study report of Part 1 of the study will be submitted as part of new drug application.

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