RecruitingPhase 2NCT06325696

H01 in Adults With Interstitial Lung Disease (The SOLIS Study)

Phase IIa Investigation of H01 in Adults With Interstitial Lung Disease (The SOLIS Study)


Sponsor

National Institute of Environmental Health Sciences (NIEHS)

Enrollment

37 participants

Start Date

May 5, 2025

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called hymecromone for people with idiopathic pulmonary fibrosis, interstitial lung disease, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGhymecromone

400 mg


Locations(1)

NIEHS Clinical Research Unit (CRU)

Research Triangle Park, North Carolina, United States

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NCT06325696


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