NCT06325696

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: National Institute of Environmental Health Sciences (NIEHS) · NIH
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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. Tests will be repeated at study visits.

Detailed description

Study Description: Phase 2a, open-label, study to evaluate the safety, tolerability, and efficacy of H01 in adults with progressive interstitial lung disease. Up to 37 participants will be enrolled. Objectives: Primary Objective: Evaluate the efficacy of H01 in reducing hyaluronan levels in participants with progressive interstitial lung disease. Secondary Objectives: * Evaluate the safety and tolerability of oral H01 in participants with progressive interstitial lung disease. * Evaluate the change in clinical and functional measures in participants with progressive interstitial lung disease treated with H01. * Evaluate biomarkers of fibrosis in participants with progressive interstitial lung disease treated with H01. * Evaluate pharmacokinetic changes from baseline in participants with progressive interstitial lung disease treated with H01 Endpoints: Primary Endpoint: Serum HA levels before and after initiation of treatment with H01 over a period of 12 weeks. Secondary Endpoints: * Safety and tolerability (according to Common Terminology Criteria for Adverse Events) * Change in sputum hyaluronan levels * Change in 6-minute walk test (6MWT) * Change in pulmonary function test (PFT) including: FVC, DLCO * Change in symptom score on Saint George s Respiratory Questionnaire (SGRQ) and King s Brief Interstitial Lung Disease (KBILD) Questionnaire * Change in right ventricular (RV) pressures in echocardiography before treatment and after 12 weeks of H01 treatment * RV Systolic Pressure, Right Atrial Pressure, presence of pericardial effusion, RV size and function via Tricuspid Annular Plane Systolic Excursion /RV Fractional Area Change, Left Ventricular function and Ejection Fraction Exploratory: * Markers of fibrosis (e.g., monocyte count, monocyte/lymphocyte ratio, cytokine analysis (other, e.g., circulating fibrocytes) * Pharmacokinetic changes from baseline to study visits and study follow-up for H01 and active metabolite (4-MU, and 4-MUG)

Conditions

• Interstitial Lung Disease
• Idiopathic Pulmonary Fibrosis
• Lung Diseases, Interstitial

Interventions

Type	Name	Description
DRUG	hymecromone	400 mg

Timeline

• Start date: 2025-05-05
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2024-03-22
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study