protocolSection identificationModule nctId: NCT06325696, orgStudyIdInfo id: 10001577, secondaryIdInfos id: 001577-E, briefTitle: H01 in Adults With Interstitial Lung Disease (The SOLIS Study), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: National Institute of Environmental Health Sciences (NIEHS), class: NIH, descriptionModule briefSummary: 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., conditionsModule conditions: Interstitial Lung Disease, conditions: Idiopathic Pulmonary Fibrosis, conditions: Lung Diseases, Interstitial, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 37, type: ESTIMATED, armsInterventionsModule interventions name: hymecromone, outcomesModule primaryOutcomes measure: To evaluate the efficacy of H01 in reducing serum hyaluronan levels in participants with progressive ILD, secondaryOutcomes measure: Evaluate the safety and tolerability of oral H01 in participants with progressive ILD., secondaryOutcomes measure: Evaluate the change in clinical and functional measures in participants with progressive ILD treated with H01., secondaryOutcomes measure: Evaluate biomarkers of fibrosis in participants with progressive ILD treated with H01., secondaryOutcomes measure: Evaluate pharmacokinetic changes from baseline in participants with progressive ILD treated with H01., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 100 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NIEHS Clinical Research Unit (CRU), city: Research Triangle Park, state: North Carolina, zip: 27709, country: United States, contacts name: NIEHS Join A Study Recruitment Group, role: CONTACT, phone: 855-696-4347, email: myniehs@nih.gov, geoPoint lat: 35.90567, lon: -78.90497, hasResults: False