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

Part of paid clinical trials in Stanford, California.

Sponsor
Joseph C. Wu
Study ID
NCT06872112
Phase
PHASE1
Status
Recruiting
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Conditions

  • Pulmonary Arterial Hypertension (PAH)

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Artesunate — DRUG
    Participants will receive artesunate capsules. Participants will receive artesunate capsules TID in a dose escalation manner (60 mg, 120 mg, 180 mg total daily).

Study Details

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.

Key Dates

Start date
Apr 1, 2026
Status verified
Apr 2026
Primary completion
Jan 1, 2029
Completion
Jan 1, 2029

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Number of Participants with treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 16 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305
Roham Zamanian, MD
[email protected]
(650) 725-7061

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By research site
Stanford University· Stanford, CA

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