Recruiting
Phase 1

Artesunate

Sponsor:

Joseph C. Wu

Code:

NCT06872112

Conditions

Pulmonary Arterial Hypertension (PAH)

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Artesunate

Study Details

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.

Conditions

Pulmonary Arterial Hypertension (PAH)

Study ID

NCT06872112

Start date

Apr 1, 2026

Status verified date

Apr, 2026

Completion date

Jan 1, 2029

Anticipated

Primary completion date

Jan 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Participants who meet any of the following criteria will be excluded from the study.
  • Participants with serious concomitant morbidity per investigator assessment.

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Artesunate

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

Primary outcome measure

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

Central Contacts and Locations

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Roham Zamanian, MD

(650) 725-7061roham.zamanian@stanford.edu

More Information

Sponsor

Joseph C. Wu

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Keywords

  • Pulmonary Arterial Hypertension
  • Artesunate
  • PAH

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Joseph C. Wu on 2026-04-23.