NCT06325696

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

Recruiting now Phase 2 Last updated 27 February 2026

What this trial tests

Phase 2 trial testing hymecromone in Interstitial Lung Disease in 37 participants. Currently enrolling.

Timeline

5 May 2025

Primary endpoint
31 December 2027

31 December 2027

Quick facts

Lead sponsor	National Institute of Environmental Health Sciences (NIEHS)
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	37
Start date	5 May 2025
Primary completion	31 December 2027
Estimated completion	31 December 2027
Sites	1 location across United States

Drugs / interventions tested

• hymecromone (HYMECROMONE) — full drug profile →

Conditions studied

• Interstitial Lung Disease — all drugs for Interstitial Lung Disease →
• Idiopathic Pulmonary Fibrosis — all drugs for Idiopathic Pulmonary Fibrosis →
• Lung Diseases, Interstitial — all drugs for Lung Diseases, Interstitial →

Sponsor

National Institute of Environmental Health Sciences (NIEHS)

Who can join

Adults 18 to 100, any sex, with Interstitial Lung Disease or Idiopathic Pulmonary Fibrosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Clinical Insights and Therapeutic Strategies for the Treatment of Interstitial Lung Disease in Patients with Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis: Current Trends and Future Directions.
   Fijolek J, Sniady A. · · 2025 · cited 1× · PMID 40649005 · DOI 10.3390/jcm14134631