Hymecromone for Interstitial Lung Disease

Recruiting at 1 trial location

Overseen By Stavros Garantziotis, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: National Institute of Environmental Health Sciences (NIEHS)

Must not be taking: UDP-glucuronosyltransferase inhibitors

Disqualifiers: Lung transplant list, Oxygen at rest, Celiac disease, Cirrhosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

37 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on certain medications that affect liver enzymes or if you have changed your ILD medication dose in the last 3 months.

Research Team

Stavros Garantziotis, M.D.

Principal Investigator

National Institute of Environmental Health Sciences (NIEHS)

Eligibility Criteria

Adults with progressive interstitial lung disease, including conditions like idiopathic pulmonary fibrosis and other forms of pulmonary fibrosis, are eligible for this trial. Participants must be willing to undergo various tests to measure the effectiveness of H01 in treating their condition.

Inclusion Criteria

I am willing and able to follow the study's procedures for its entire duration.

DLCO>30% <80%, FVC>45% and <80%

I am older than 18 years.

Exclusion Criteria

Known allergy to hymecromone or any component thereof

Physician concern that participant may not adhere to the study protocol

I need extra oxygen when I am resting.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Participants undergo baseline assessments including blood tests, heart function tests, spirometry, diffusion capacity, resting energy expenditure, and 6-minute walk test

1-2 weeks

1 visit (in-person)

Treatment

Participants take 2 tablets of H01 every morning and 2 tablets every night for 12 weeks. Tests are repeated at study visits.

12 weeks

At least 5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• H01

Trial Overview The SOLIS study is testing the safety and potential benefits of an oral medication called hymecromone (H01). It aims to see if H01 can lower hyaluronan levels in the blood and improve lung function over a period of 12 weeks.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

Adults, male and female with a diagnosis of interstitial lung disease, take 2 doses of 400 mg H01, morning and evening

Who Is Running the Clinical Trial?

National Institute of Environmental Health Sciences (NIEHS)

Lead Sponsor

Trials

294

Recruited

1,233,000+