Dose-Escalation Study of Artesunate Patients With IPF
Public ClinicalTrials.gov record NCT05988463. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Dose-Escalation Study Evaluating the Safety and Tolerability of Artesunate in Participants With Idiopathic Pulmonary Fibrosis (SAFE-IPF)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05988463
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 15 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2026
- Primary completion
- Oct 31, 2028
- Completion
- Oct 31, 2028
- Last update posted
- Aug 10, 2026
2026 – 2028
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05988463, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 10, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05988463 live on ClinicalTrials.gov.