Idiopathic Pulmonary FibrosisPhase 1SAFE-IPFNCT05988463
Dose-Escalation Study of Artesunate Patients With IPF
A Phase 1 study testing Artesuante in people with Idiopathic Pulmonary Fibrosis, run by Joseph C. Wu at 1 site in United States.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- Artesuante
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to 1 Nov 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Each participant must meet the following criteria to be enrolled in this study:
- Age 40 years or older.
- Diagnosis of IPF based upon ATS/ERS/JRS/ALAT 2018 guidelines (56)
- FVC percent of predicted ≥ 30%; historical FVC for entry in the study is permitted if within 3 months of screening.
- Diffusing capacity of lung for carbon monoxide (DLco) (hemoglobin-adjusted) ≥ 25%; historical DLco for entry in the study is permitted if within 3 months of screening.
- Participants receiving nintedanib, pirfenidone, and/or nerandomilast for the treatment of idiopathic pulmonary fibrosis (IPF), including combination therapy (e.g., nintedanib plus nerandomilast or pirfenidone plus nerandomilast), are eligible for enrollment. All background IPF therapies must be stable for at least 6 weeks prior to the Screening visit and taken continuously with no or only rare interruptions.
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- Female participants of childbearing potential (i.e., ovulating, premenopausal, and not surgically sterile) and all male participants with sexual partners of childbearing potential agree to use highly effective methods of birth control during their participation in the study and for 60 days after the last administration of study drug. Women of child-bearing potential are defined as any female who has experienced menarche and who is not permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.
- Highly effective methods of birth control are defined as those with 99% or greater efficacy and includes:
- Use of hormonal contraception that inhibits ovulation, administered orally, by injection, implant, transdermal patch, or vaginal ring Vasectomized male partner Sexual abstinence, only if it is the participant's consistent and preferred lifestyle Infertile partner, confirmed by medical evaluation
- Participants must agree to abstain from egg or sperm donation through 60 days after administration of the last dose of study drug.
- Able to read and sign a written informed consent form (ICF).
- 7.3 Exclusion Criteria Participants who meet any of the following criteria will be excluded from the study.
- Receiving any nonapproved agent intended for treatment of fibrosis in IPF or participation in other treatment clinical trials.
- Clinical evidence of active infection within 30 days of screening, including but not limited to bronchitis, pneumonia, or sinusitis that can affect FVC measurement during screening.
- Known acute IPF exacerbation, or suspicion by the Investigator of such, within 3 months of screening.
- The extent of emphysema is greater than the fibrotic changes on the most recent HRCT scan as determined by PI.
- Any medical condition, not limited to cardiac, hepatic, renal disease or malignancy, in recent months that will make the participants unsuitable for the study, as judged by the PI.
- Any of the following liver test results above the listed specified limits: total bilirubin >2× the upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3× ULN; alkaline phosphatase (ALP) > 2.5× ULN, pending PI's discretion.
- Hemoglobin < 10.0 g/dL.
- Pregnant or lactating.
- Likely to undergo lung transplantation during the study (being on transplantation list is acceptable).
- Currently receiving and expected to remain on treatment during the study with drugs interacting with artesunate including amodiaquine, and efavirenz, nevirapine and ritonavir.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Stanford, California, 94305
About this study
Official title: A Dose-Escalation Study Evaluating the Safety and Tolerability of Artesunate in Participants With Idiopathic Pulmonary Fibrosis (SAFE-IPF)
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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- Artesuante, Placebo capsules
- Keywords
- shortness of breath, fibrosis, cough, hypoxemia
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Dyspnea, Fibrosis, Cough, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArtesuanteDrug
Artesunate capsules administered orally twice daily beginning at 20 mg for 4 weeks, followed by 40 mg for 4 weeks, and then 60 mg for 4 weeks.
Placebo capsulesOther
Placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Artesunate | Experimental | Experimental group Receives: Drug: Artesuante; Other: Placebo capsules |
| Placebo | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who experience treatment-related adverse events
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Aug 2026
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RAndomized double blind label, dose escalation treatment study
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joseph C. Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joseph C. Wu, Stanford University
- Investigators
- Joshua Mooney, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988463
- Sponsor's protocol ID
- 71488
- Acronym
- SAFE-IPF
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2023
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Escalation Study Evaluating the Safety and Tolerability of Artesunate in Participants With Idiopathic Pulmonary Fibrosis (SAFE-IPF)
- ClinicalTrials.gov ID
- NCT05988463
- Acronym / sponsor ID
- SAFE-IPF / 71488
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- shortness of breath, fibrosis, cough, hypoxemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Joseph C. WuUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RAndomized double blind label, dose escalation treatment study
| Arm | Type | Receives |
|---|---|---|
| Artesunate | Experimental | Drug: Artesuante, Other: Placebo capsulesExperimental group |
| Placebo | No intervention | –Control |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age 40 years or older.
- Diagnosis of IPF based upon ATS/ERS/JRS/ALAT 2018 guidelines (56)
- FVC percent of predicted ≥ 30%; historical FVC for entry in the study is permitted if within 3 months of screening.
- Diffusing capacity of lung for carbon monoxide (DLco) (hemoglobin-adjusted) ≥ 25%; historical DLco for entry in the study is permitted if within 3 months of screening.
- Participants receiving nintedanib, pirfenidone, and/or nerandomilast for the treatment of idiopathic pulmonary fibrosis (IPF), including combination therapy (e.g., nintedanib plus nerandomilast or pirfenidone plus nerandomilast), are eligible for enrollment. All background IPF therapies must be stable for at least 6 weeks prior to the Screening visit and taken continuously with no or only rare interruptions.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArtesuanteArtesunate capsules administered orally twice daily beginning at 20 mg for 4 weeks, followed by 40 mg for 4 weeks, and then 60 mg for 4 weeks. | Drug | Artesunate |
| Placebo capsulesPlacebo capsules | Other | Artesunate |
Primary outcome
Number of participants who experience treatment-related adverse events
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joshua Mooney, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Artesuante in people with Idiopathic Pulmonary Fibrosis, run by Joseph C. Wu at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph Wu, M.D, Ph.D. ((650) 736-2246, joewu@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who experience treatment-related adverse events (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.