Interstitial Lung DiseasePhase 2NCT06325696
H01 in Adults With Interstitial Lung Disease (The SOLIS Study)
A Phase 2 study testing hymecromone in people with Interstitial Lung Disease and Idiopathic Pulmonary Fibrosis, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial summary
Background: Interstitial lung disease affects the tissues that aid the transfer of oxygen and carbon dioxide between the air and the bloodstream. The disease can cause fibrosis, a thickening and scarring of lung tissue. Fibrosis often continues getting worse, and most people with this disease die in 3 to 5 years. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis, Lung Diseases, Interstitial
- What is being tested?
- hymecromone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2025to 31 Dec 2027
- Phase
- Phase 2
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Ability of subject to understand, and the willingness to sign a written informed consent document and comply with requirements of the study
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or Female participants ages >18 years
- MD diagnosis of Idiopathic Pulmonary Fibrosis or other progressive ILD as defined previously
- DLCO>30% and FVC>45%
- Subjects in reproductive age who are heterosexually active must use an acceptable method of contraception: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, IUD, or Hormone-based contraceptive
- Agreement to adhere to Lifestyle Considerations throughout study duration
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Active on lung transplantation list
- On supplemental oxygen at rest
- Evidence of an acute respiratory infection or exacerbation of pulmonary fibrosis
- Known diagnosis of celiac disease or wheat or gluten allergies
- Cirrhosis or active viral or non-viral hepatitis: Bilirubin, AST and ALT values higher than twice the upper range of normal, or a Child-Pugh score of 7 or more
Show all 20Show fewer
- Subjects with history of active Inflammatory Bowel Disease, dysphagia, achalasia, or difficulty swallowing capsules, tablets or pills
- Subjects with significant renal impairment defined as eGFR lower than 40 ml/min.
- Subjects with a baseline corrected Fridericia's QT interval (QTcF) >450ms or baseline ECG abnormalities which, in the opinion of the study physician, are clinically significant and would place the participant at increased risk for adverse effects.
- Subjects with ongoing alcohol or illegal drug use disorder
- Subjects who are pregnant, lactating or attempting to conceive
- Participants able to become pregnant (have not completed menopause, had a hysterectomy and/or both tubes and/or both ovaries removed) must use effective birth control methods to try and not become pregnant while participant in this study. Methods include (a) partner vasectomy, (b) bilateral tubal ligation, (c) intrauterine devices (IUDs), (d) hormonal implants (such as Implanon), or (e) other hormonal methods (birth control pills, injections, patches, vaginal rings).
- Male participants able to father children with a partner able to become pregnant must agree to use effective birth control (listed above) to participate in this study.
- Known allergy to hymecromone or any component thereof
- Chronic therapy with medications that are known potent human UDP-glucuronosyltransferase inhibitors: canagliflozin, temazepam, tacrolimus.
- Physician concern that participant may not adhere to the study protocol
- Current participation in another clinical treatment trial for ILD. May participate after 12 weeks from conclusion of another treatment trial.
- Changing dose of other ILD medications over the 3 months prior to baseline
- Any condition(s) or diagnosis, both physical or psychological, or physical exam finding that place the participant at increased risk for adverse effects, as determined by the study physician.
- Participants who completed the original 12-week treatment portion of the SOLIS study prior to the implementation of the optional 12-week extension phase may have the option to re-enroll under the amended protocol, after an appropriate washout period of up to 6 months. Participants will be re-screened as per criteria above to ensure that eligibility criteria continue to be met. Once eligibility is confirmed, participants can complete the 12-week treatment and optional 12-week extension for a maximum treatment period of 24 weeks. These re-enrolled participants will be enrolled as new participants and receive a different screening number to differentiate them from the original enrollment.
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
NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina, 27709
NIEHS Join A Study Recruitment Group, 855-696-4347, myniehs@nih.gov
About this study
Official title: Phase IIa Investigation of H01 in Adults With Interstitial Lung Disease (The SOLIS Study)
Background:
Interstitial lung disease affects the tissues that aid the transfer of oxygen and carbon dioxide between the air and the bloodstream. The disease can cause fibrosis, a thickening and scarring of lung tissue. Fibrosis often continues getting worse, and most people with this disease die in 3 to 5 years.
Read more
Objective:
To test a study drug (hymecromone) in people with interstitial lung disease or lung fibrosis.
Eligibility:
People aged 18 years and older with interstitial lung disease or lung fibrosis.
Design:
Participants will have at least 7 clinic visits over 5 months.
Participants will have screening and baseline visits. They will have blood tests and tests of their heart function. They will give a sputum sample. Other tests will include:
Spirometry: Participants will breathe in and out through a mouthpiece to measure how much air they can hold in their lungs and how hard they can breathe.
Diffusion capacity of lungs for carbon monoxide: Participants will breathe in a gas that contains a small amount of carbon monoxide. Then they will breathe through a mouthpiece. This test measures how well oxygen moves from the air into the blood.
Resting energy expenditure. Participants will lie still for 30 minutes with a clear dome over their head. This test measures the calories their body burns at rest.
6-minute walk test. Participants will walk at their normal pace for 6 minutes. Their vital signs and blood oxygen levels will be checked.
Hymecromone is a tablet taken by mouth. Participants will take 2 tablets every morning and 2 tablets every night for 12 weeks. Participants who decide to continue longer may enter an optional 12 week extension phase, for a maximum treatment time of 24 weeks. Tests will be repeated at study visits.
Read the detailed description
Study Description:
Phase 2a, open-label, study to evaluate the safety, tolerability, and efficacy of H01 in adults with progressive interstitial lung disease. Up to 37 participants will be enrolled.
Objectives:
Primary Objective: Evaluate the efficacy of H01 in reducing hyaluronan levels in participants with progressive interstitial lung disease.
Secondary Objectives:
- Evaluate the safety and tolerability of oral H01 in participants with progressive interstitial lung disease.
- Evaluate the change in clinical and functional measures in participants with progressive interstitial lung disease treated with H01.
- Evaluate biomarkers of fibrosis in participants with progressive interstitial lung disease treated with H01.
- Evaluate pharmacokinetic changes from baseline in participants with progressive interstitial lung disease treated with H01
Endpoints:
Primary Endpoint: Serum HA levels before and after initiation of treatment with H01 over a period of 12 weeks.
Secondary Endpoints:
- Safety and tolerability (according to Common Terminology Criteria for Adverse Events)
- Change in sputum hyaluronan levels
- Change in 6-minute walk test (6MWT)
- Change in pulmonary function test (PFT) including: FVC, DLCO
- Change in symptom score on Saint George s Respiratory Questionnaire (SGRQ) and King s Brief Interstitial Lung Disease (KBILD) Questionnaire
- Change in right ventricular (RV) pressures in echocardiography before treatment and after H01 treatment
- RV Systolic Pressure, Right Atrial Pressure, presence of pericardial effusion, RV size and function via Tricuspid Annular Plane Systolic Excursion /RV Fractional Area Change, Left Ventricular function and Ejection Fraction
Exploratory:
- Markers of fibrosis (e.g., monocyte count, monocyte/lymphocyte ratio, cytokine analysis (other, e.g., circulating fibrocytes)
- Pharmacokinetic changes from baseline to study visits and study follow-up for H01 and active metabolite (4-MU, and 4-MUG)
- Serum HA levels before and after initiation of treatment with H01 over a period of 24 weeks in participants who complete the optional 12-week extension phase.
- Being tested
- hymecromone
- Keywords
- Pulmonary Fibrosis, Lung disease, Hyaluronan, Drug
- Medical subject headings
- Lung Diseases, Interstitial, Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hymecromoneDrug
400 mg
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Adults, male and female with a diagnosis of interstitial lung disease, take 2 doses of 400 mg H01, morning and evening Receives: Drug: hymecromone |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of H01 in reducing serum hyaluronan levels in participants with progressive ILD
Measured: Serum HA levels before and after initiation of treatment with H01 over a period of 12 weeks
Secondary outcomes (5)
Evaluate the safety and tolerability of oral H01 in participants with progressive ILD.
Measured: On-going throughout study; each study visit
Evaluate the change in clinical and functional measures in participants with progressive ILD treated with H01.
Measured: On-going throughout study; each study visit
Evaluate biomarkers of fibrosis in participants with progressive ILD treated with H01.
Measured: On-going throughout study; each study visit
Evaluate pharmacokinetic changes from baseline in participants with progressive ILD treated with H01.
Measured: On-going throughout study; each study visit
Evaluate the efficacy of H01 in reducing serum hyaluronan levels in participants with progressive ILD.
Measured: Serum HA levels before and after initiation of treatment with H01 over a period of 24 weeks in participants who complete the optional 12-week extension phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start5 May 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Stavros Garantziotis, M.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325696
- Sponsor's protocol ID
- 10001577
- Other IDs
- 001577-E
- Status last verified
- 23 Jul 2026
- First submitted
- 21 Mar 2024
- Last updated
- 28 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if individual participant data will be shared.
Publications
Garantziotis S, Steele MP, Schwartz DA. Pulmonary fibrosis: thinking outside of the lung. J Clin Invest. 2004 Aug;114(3):319-21. doi: 10.1172/JCI22497.
PubMed 15286797Raghu G, Chen SY, Yeh WS, Maroni B, Li Q, Lee YC, Collard HR. Idiopathic pulmonary fibrosis in US Medicare beneficiaries aged 65 years and older: incidence, prevalence, and survival, 2001-11. Lancet Respir Med. 2014 Jul;2(7):566-72. doi: 10.1016/S2213-2600(14)70101-8. Epub 2014 May 27.
PubMed 24875841Navaratnam V, Fleming KM, West J, Smith CJ, Jenkins RG, Fogarty A, Hubbard RB. The rising incidence of idiopathic pulmonary fibrosis in the U.K. Thorax. 2011 Jun;66(6):462-7. doi: 10.1136/thx.2010.148031. Epub 2011 Apr 27.
PubMed 21525528Lederer DJ, Martinez FJ. Idiopathic Pulmonary Fibrosis. N Engl J Med. 2018 Aug 23;379(8):797-798. doi: 10.1056/NEJMc1807508. No abstract available.
PubMed 30134133
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa Investigation of H01 in Adults With Interstitial Lung Disease (The SOLIS Study)
- ClinicalTrials.gov ID
- NCT06325696
- Acronym / sponsor ID
- 10001577
- Keywords
- Pulmonary Fibrosis, Lung disease, Hyaluronan, Drug
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 5 May 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Mar 2024 (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.
Background:
Interstitial lung disease affects the tissues that aid the transfer of oxygen and carbon dioxide between the air and the bloodstream. The disease can cause fibrosis, a thickening and scarring of lung tissue. Fibrosis often continues getting worse, and most people with this disease die in 3 to 5 years.
Objective:
To test a study drug (hymecromone) in people with interstitial lung disease or lung fibrosis.
Eligibility:
People aged 18 years and older with interstitial lung disease or lung fibrosis.
Design:
Participants will have at least 7 clinic visits over 5 months.
Participants will have screening and baseline visits. They will have blood tests and tests of their heart function. They will give a sputum sample. Other tests will include:
Spirometry: Participants will breathe in and out through a mouthpiece to measure how much air they can hold in their lungs and how hard they can breathe.
Diffusion capacity of lungs for carbon monoxide: Participants will breathe in a gas that contains a small amount of carbon monoxide. Then they will breathe through a mouthpiece. This test measures how well oxygen moves from the air into the blood.
Resting energy expenditure. Participants will lie still for 30 minutes with a clear dome over their head. This test measures the calories their body burns at rest.
6-minute walk test. Participants will walk at their normal pace for 6 minutes. Their vital signs and blood oxygen levels will be checked.
Hymecromone is a tablet taken by mouth. Participants will take 2 tablets every morning and 2 tablets every night for 12 weeks. Participants who decide to continue longer may enter an optional 12 week extension phase, for a maximum treatment time of 24 weeks. Tests will be repeated at study visits.
Detailed description
Study Description:
Phase 2a, open-label, study to evaluate the safety, tolerability, and efficacy of H01 in adults with progressive interstitial lung disease. Up to 37 participants will be enrolled.
Objectives:
Primary Objective: Evaluate the efficacy of H01 in reducing hyaluronan levels in participants with progressive interstitial lung disease.
Secondary Objectives:
- Evaluate the safety and tolerability of oral H01 in participants with progressive interstitial lung disease.
- Evaluate the change in clinical and functional measures in participants with progressive interstitial lung disease treated with H01.
- Evaluate biomarkers of fibrosis in participants with progressive interstitial lung disease treated with H01.
- Evaluate pharmacokinetic changes from baseline in participants with progressive interstitial lung disease treated with H01
Endpoints:
Primary Endpoint: Serum HA levels before and after initiation of treatment with H01 over a period of 12 weeks.
Secondary Endpoints:
- Safety and tolerability (according to Common Terminology Criteria for Adverse Events)
- Change in sputum hyaluronan levels
- Change in 6-minute walk test (6MWT)
- Change in pulmonary function test (PFT) including: FVC, DLCO
- Change in symptom score on Saint George s Respiratory Questionnaire (SGRQ) and King s Brief Interstitial Lung Disease (KBILD) Questionnaire
- Change in right ventricular (RV) pressures in echocardiography before treatment and after H01 treatment
- RV Systolic Pressure, Right Atrial Pressure, presence of pericardial effusion, RV size and function via Tricuspid Annular Plane Systolic Excursion /RV Fractional Area Change, Left Ventricular function and Ejection Fraction
Exploratory:
- Markers of fibrosis (e.g., monocyte count, monocyte/lymphocyte ratio, cytokine analysis (other, e.g., circulating fibrocytes)
- Pharmacokinetic changes from baseline to study visits and study follow-up for H01 and active metabolite (4-MU, and 4-MUG)
- Serum HA levels before and after initiation of treatment with H01 over a period of 24 weeks in participants who complete the optional 12-week extension phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: hymecromoneAdults, male and female with a diagnosis of interstitial lung disease, take 2 doses of 400 mg H01, morning and evening |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Ability of subject to understand, and the willingness to sign a written informed consent document and comply with requirements of the study
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or Female participants ages >18 years
- MD diagnosis of Idiopathic Pulmonary Fibrosis or other progressive ILD as defined previously
Key exclusion criteria (20 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Active on lung transplantation list
- On supplemental oxygen at rest
- Evidence of an acute respiratory infection or exacerbation of pulmonary fibrosis
- Known diagnosis of celiac disease or wheat or gluten allergies
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 |
|---|---|---|
| hymecromone400 mg | Drug | Treatment |
Primary outcome
To evaluate the efficacy of H01 in reducing serum hyaluronan levels in participants with progressive ILD
Time frame: Serum HA levels before and after initiation of treatment with H01 over a period of 12 weeks
5 secondary outcomes
Evaluate the safety and tolerability of oral H01 in participants with progressive ILD.
Time frame: On-going throughout study; each study visit
Evaluate the change in clinical and functional measures in participants with progressive ILD treated with H01.
Time frame: On-going throughout study; each study visit
Evaluate biomarkers of fibrosis in participants with progressive ILD treated with H01.
Time frame: On-going throughout study; each study visit
Evaluate pharmacokinetic changes from baseline in participants with progressive ILD treated with H01.
Time frame: On-going throughout study; each study visit
Evaluate the efficacy of H01 in reducing serum hyaluronan levels in participants with progressive ILD.
Time frame: Serum HA levels before and after initiation of treatment with H01 over a period of 24 weeks in participants who complete the optional 12-week extension phase.
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 28 Jul 2026.
- Background: PubMed 15286797Garantziotis S, Steele MP, Schwartz DA. Pulmonary fibrosis: thinking outside of the lung. J Clin Invest. 2004 Aug;114(3):319-21. doi: 10.1172/JCI22497.
- Background: PubMed 24875841Raghu G, Chen SY, Yeh WS, Maroni B, Li Q, Lee YC, Collard HR. Idiopathic pulmonary fibrosis in US Medicare beneficiaries aged 65 years and older: incidence, prevalence, and survival, 2001-11. Lancet Respir Med. 2014 Jul;2(7):566-72. doi: 10.1016/S2213-2600(14)70101-8. Epub 2014 May 27.
- Background: PubMed 21525528Navaratnam V, Fleming KM, West J, Smith CJ, Jenkins RG, Fogarty A, Hubbard RB. The rising incidence of idiopathic pulmonary fibrosis in the U.K. Thorax. 2011 Jun;66(6):462-7. doi: 10.1136/thx.2010.148031. Epub 2011 Apr 27.
- Background: PubMed 30134133Lederer DJ, Martinez FJ. Idiopathic Pulmonary Fibrosis. N Engl J Med. 2018 Aug 23;379(8):797-798. doi: 10.1056/NEJMc1807508. No abstract available.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. It is not yet known if individual participant data will be shared.
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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.
Stavros Garantziotis, M.D. principal investigator
National Institute of Environmental Health Sciences (NIEHS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hymecromone in people with Interstitial Lung Disease and Idiopathic Pulmonary Fibrosis, run by National Institute of Environmental Health Sciences (NIEHS) 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 8 inclusion and 20 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 28 Jul 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 NIEHS Join A Study Recruitment Group ((855) 696-4347, myniehs@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of H01 in reducing serum hyaluronan levels in participants with progressive ILD (time frame: Serum HA levels before and after initiation of treatment with H01 over a period of 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06325696, which also lists 4 linked publications.
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 28 Jul 2026.