Study of Oral Hymecromone for Adults With Progressive Interstitial Lung Disease and Lung Fibrosis

What this Trial Is About

This research aims to evaluate the effects of the study drug hymecromone in adults with interstitial lung disease or lung fibrosis, conditions that cause thickening and scarring of lung tissue, often worsening over time and leading to serious outcomes. The study is a Phase 2a open-label trial enrolling up to 37 participants with progressive interstitial lung disease. The main goal is to assess how hymecromone influences serum hyaluronan levels and other related biomarkers. Participants will take hymecromone tablets, 400 mg twice daily 2 tablets in the morning and 2 at night, for 12 weeks. Those who wish may continue for an optional 12-week extension, making the maximum treatment period 24 weeks. The study includes at least seven clinic visits over five months, with repeated testing during the treatment and extension phases. During the study, participants will undergo various assessments including blood tests, heart function tests, sputum collection, spirometry to measure lung capacity, diffusion capacity tests for oxygen transfer, resting energy expenditure measurement, and a 6-minute walk test to evaluate physical function. Researchers will monitor safety, tolerability, lung function, symptoms, and biomarker changes throughout the study. The total participation duration is about five months, including the optional extension for some.

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