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

Part of paid clinical trials in Research Triangle Park, North Carolina.

Sponsor
National Institute of Environmental Health Sciences (NIEHS)
Study ID
NCT06325696
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • hymecromone — DRUG
    400 mg

Study Details

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.

Key Dates

Start date
May 5, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

To evaluate the efficacy of H01 in reducing serum hyaluronan levels in participants with progressive ILD [ Time Frame: Serum HA levels before and after initiation of treatment with H01 over a period of 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NIEHS Clinical Research Unit (CRU)Research Triangle ParkNorth Carolina27709
NIEHS Join A Study Recruitment Group
[email protected]
855-696-4347

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NIEHS Clinical Research Unit (CRU)· Research Triangle Park, NC

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