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

Phase 1

Not yet recruiting

• Conditions: Pulmonary Arterial Hypertension (PAH)
• Interventions: Drug: Artesunate

• Registration Number: NCT06872112
• Lead Sponsor: Joseph C. Wu

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-06
• Study First Posted: 2025-03-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Study Start: 2026-01-01
• Primary Completion: 2029-01-01
• Study Completion: 2029-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Label Treatment Arm	Artesunate	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

Primary Outcome Measures

Name	Time	Method
Number of Participants with treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs)	16 weeks

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States