Phase I Study: A Dose-Escalation Study Evaluating the Safety and Tolerability of Artesunate in Patients With Pulmonary Arterial Hypertension
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This is a 20-week, Phase 1, single-center, open-label, dose-escalation study evaluating the safety and tolerability of daily oral artesunate in patients with PAH.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
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• Each participant must meet the following criteria to be enrolled in this study:
• Adults aged 18 to 75 years.
• WHO functional class I, II/III despite treatment with maximally tolerated doses of 2 or more treatment modalities including PDE5 inhibitors, guanylate cyclase stimulators, endothelin receptor antagonists, and prostanoids when appropriate.
Locations
United States
California
Stanford University
RECRUITING
Stanford
Time Frame
Start Date: 2026-04-01
Estimated Completion Date: 2029-01-01
Participants
Target number of participants: 15
Treatments
Experimental: Open Label Treatment Arm
Dose escalating study with a Follow-up (washout) Period:~Total study period of the open-label study: 14 weeks Screening Period: up to 4 weeks Treatment Period (20 mg TID): 4 weeks Treatment Period (40 mg TID): 4 weeks Treatment Period (60 mg TID): 4 weeks Follow-up (washout) Period: 2 weeks after treatment period ends
Related Therapeutic Areas
Sponsors
Leads: Joseph C. Wu