The SOLIS Study: H01 for Interstitial Lung Disease
This study, called The SOLIS Study, is testing a drug called hymecromone (also known as H01) in adults with interstitial lung disease (ILD) or lung fibrosis. ILD affects the tissues that help your body get oxygen, and it can cause scarring in your lungs. Researchers want to see if hymecromone can lower levels of hyaluronan in your blood, which is a marker they are watching in people with progressive ILD. The study is currently unclear on its recruitment status and plans to enroll up to 37 participants. To join, you must be 18 years or older and have ILD or lung fibrosis. The main goal is to see how well hymecromone reduces hyaluronan levels over 12 weeks.
- Study design
- This is a Phase 2a, open-label study, meaning both you and the study team will know you are receiving hymecromone. Up to 37 participants will be enrolled.
- What's involved
- You will have at least 7 clinic visits over 5 months, including screening and baseline visits. These visits will involve blood tests, heart function tests, and providing a sputum sample.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint measures changes over a period of 12 weeks after starting treatment with H01.
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NCT06325696
H01 in Adults With Interstitial Lung Disease (The SOLIS Study)
Recruiting
PHASE2Ages 18+InterventionalTreatmentNational Institute of Environmental Health Sciences (NIEHS)Government-funded
~37 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:hymecromone
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate the efficacy of H01 in reducing serum hyaluronan levels in participants with progressive ILD
Measured over Serum HA levels before and after initiation of treatment with H01 over a period of 12 weeks
Conditions
Where it's being run
1 sites across 1 statesNorth Carolina1
Study leadership
- Stavros Garantziotis, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Environmental Health Sciences (NIEHS)
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Exclusion
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
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.
What this trial measures
- To evaluate the efficacy of H01 in reducing serum hyaluronan levels in participants with progressive ILDSerum HA levels before and after initiation of treatment with H01 over a period of 12 weeks