Actively Recruiting
H01 in Adults With Interstitial Lung Disease (The SOLIS Study)
Led by National Institute of Environmental Health Sciences (NIEHS) · Updated on 2026-02-27
37
Participants Needed
1
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. Tests will be repeated at study visits.
CONDITIONS
Official Title
H01 in Adults With Interstitial Lung Disease (The SOLIS Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign informed consent and follow study requirements
- Willing to comply with all study procedures and be available for the study duration
- Male or female participants aged over 18 years
- Diagnosed by a doctor with idiopathic pulmonary fibrosis or other progressive interstitial lung disease
- Lung function with DLCO greater than 30% and FVC greater than 45%
- Participants of reproductive age who are sexually active with partners of the opposite sex must use acceptable contraception methods
- Agreement to follow lifestyle considerations during the study
You will not qualify if you...
- Currently active on a lung transplant list
- Using supplemental oxygen at rest
- Having an acute respiratory infection or worsening of pulmonary fibrosis
- Known celiac disease or allergies to wheat or gluten
- Cirrhosis or active hepatitis with abnormal liver tests or high Child-Pugh score
- History of active inflammatory bowel disease, swallowing difficulties, or trouble taking pills
- Significant kidney impairment with eGFR below 40 ml/min
- Baseline prolonged QT interval on ECG or other significant ECG abnormalities
- Ongoing alcohol or illegal drug use disorder
- Pregnant, breastfeeding, or trying to conceive
- Known allergy to hymecromone or any of its components
- Taking medications that strongly inhibit UDP-glucuronosyltransferase enzymes
- Study physician’s concern about participant’s ability to follow the protocol
- Currently enrolled in another ILD treatment trial or changed ILD medication doses within 3 months before baseline
- Any physical or psychological condition increasing risk for adverse effects as judged by the study physician
AI-Screening
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Trial Site Locations
Total: 1 location
1
NIEHS Clinical Research Unit (CRU)
Research Triangle Park, North Carolina, United States, 27709
Actively Recruiting
Research Team
N
NIEHS Join A Study Recruitment Group
CONTACT
S
Stavros Garantziotis, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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