Phase 1 Study to Test Safety and Tolerability of Artesunate in Adults With Pulmonary Arterial Hypertension

What this Trial Is About

Researchers are conducting a 20-week, Phase 1, single-center, open-label study to evaluate the safety and tolerability of daily oral artesunate in adults with pulmonary arterial hypertension PAH. This study focuses on patients who continue to experience symptoms despite treatment with multiple standard therapies. The goal is to understand how well artesunate is tolerated and to monitor any related side effects in this patient group. Participants will receive artesunate capsules taken three times daily. The study uses a dose escalation design, starting with 20 mg three times daily for 4 weeks, then increasing to 40 mg three times daily for another 4 weeks, followed by 60 mg three times daily for a final 4 weeks. After the treatment periods, there is a 2-week follow-up washout phase to observe any lasting effects after stopping the medication. Throughout the 14-week study period, including up to 4 weeks of screening, participants will be closely monitored for treatment-related adverse events and serious adverse events. Researchers will assess safety by recording any side effects during and after the treatment phase. The total involvement includes screening, treatment, and a follow-up period to ensure participant safety and collect important data about tolerability.

A Study Evaluating the Safety and Tolerability of Artesunate in Patients With Pulmonary Arterial Hypertension