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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

⁃ In order to be eligible to participate in this study, an individual must meet all of the following criteria:

• Ability of subject to understand, and the willingness to sign a written informed consent document and comply with requirements of the study

• Stated willingness to comply with all study procedures and availability for the duration of the study

• Male or Female participants ages \>18 years

• MD diagnosis of Idiopathic Pulmonary Fibrosis or other progressive ILD as defined previously

• DLCO\>30% and FVC\>45%

• Subjects in reproductive age who are heterosexually active must use an acceptable method of contraception: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, IUD, or Hormone-based contraceptive

• Agreement to adhere to Lifestyle Considerations throughout study duration

Locations
United States
North Carolina
NIEHS Clinical Research Unit (CRU)
RECRUITING
Research Triangle Park
Contact Information
Primary
NIEHS Join A Study Recruitment Group
myniehs@nih.gov
(855) 696-4347
Backup
Stavros Garantziotis, M.D.
garantziotis@mail.nih.gov
(984) 287-4412
Time Frame
Start Date: 2025-05-05
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 37
Treatments
Experimental: Treatment
Adults, male and female with a diagnosis of interstitial lung disease, take 2 doses of 400 mg H01, morning and evening
Sponsors
Leads: National Institute of Environmental Health Sciences (NIEHS)

This content was sourced from clinicaltrials.gov