Actively Recruiting
Phase I Dose-Escalation Study Evaluating the Safety and Tolerability of Artesunate in Pulmonary Arterial Hypertension
Led by Joseph C. Wu · Updated on 2026-04-23
15
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
A Study Evaluating the Safety and Tolerability of Artesunate in Patients With Pulmonary Arterial Hypertension
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosed with pulmonary arterial hypertension (PAH)
- WHO functional class I, II/III despite treatment with maximally tolerated doses of two or more PAH therapies including PDE5 inhibitors, guanylate cyclase stimulators, endothelin receptor antagonists, and prostanoids when appropriate
You will not qualify if you...
- Participants with serious concomitant morbidity as assessed by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - up to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks (three 4-week dosing periods)
Participants receive artesunate capsules three times daily in escalating doses over three consecutive 4-week periods.
Duration - 2 weeks
Participants are monitored during a 2-week washout period after treatment ends.
Trial Site Locations
Total: 1 location
1
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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