Dose-Escalation Study of Artesunate Patients With IPF

Part of paid clinical trials in Stanford, California.

Sponsor
Joseph C. Wu
Study ID
NCT05988463
Phase
PHASE1
Status
Recruiting
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Conditions

  • Idiopathic Pulmonary Fibrosis

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Artesuante — DRUG
    Artesunate capsules administered orally twice daily beginning at 10 mg for 4 weeks, followed by 20 mg for 4 weeks, and then 30 mg for 4 weeks.
  • Placebo capsules — OTHER
    Placebo capsules

Study Details

Idiopathic Pulmonary Fibrosis (IPF) is a chronic progressive fibrotic lung disease resulting in increasing shortness of breath, cough, and low oxygen levels as a result of lung tissue scarring . This will be a single-center randomized, double-blinded, placebo-controlled study of 20 weeks including up to 4 weeks for screening, followed by 12 weeks of oral artesunate treatment across 3 dose levels (dose escalation every 4 weeks), and 4 weeks of a washout (follow-up) period in participants with Idiopathic Pulmonary Fibrosis (IPF). The primary objective of the study is to evaluate the safety and tolerability of artesunate at 3 dose levels, and to select the dose(s) to carry forward into additional clinical testing. The secondary objective includes exploring the blood biomarkers present in participants with IPF at baseline and to investigate how those biomarkers change following artesunate treatment. The exploratory objectives include assessing the changes in the K-BILD and Leicester cough questionnaire scores and change in pulmonary function after artesunate administration.

Key Dates

Start date
Jan 1, 2027
Status verified
Nov 2025
Primary completion
Nov 1, 2027
Completion
Nov 1, 2028

Study Design

Enrollment
15 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Artesunate
    Experimental group
  • No Intervention: Placebo
    Control

Primary Outcome Measure

Number of participants who experience treatment-related adverse events [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305-

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By research site
Stanford University· Stanford, CA

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