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NCT06325696 · ClinicalTrials.gov registry record · Phase 2
H01 in Adults With Interstitial Lung Disease (The SOLIS Study)
A Phase 2 study of Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT06325696 is a Phase 2 study of Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease that is actively recruiting participants, run by National Institute of Environmental Health Sciences (NIEHS). The registered enrollment target is 37 participants, below the 751-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06325696, a Phase 2 study of Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease, is actively recruiting participants, sponsored by National Institute of Environmental Health Sciences (NIEHS).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG hymecromone
Study Locations (1)
North Carolina
- NIEHS Clinical Research Unit (CRU) - Research Triangle Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2025-05-05 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06325696
The ClinicalTrials.gov registry entry for NCT06325696 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 751-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (95% lower). The listed sponsor is National Institute of Environmental Health Sciences (NIEHS), which has 145 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Idiopathic Pulmonary Fibrosis appearing as the primary indexed condition, and to 1 intervention - of which hymecromone is the first listed.
NCT06325696 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT06325696 about?
NCT06325696 is a clinical study titled "H01 in Adults With Interstitial Lung Disease (The SOLIS Study)". 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 i...
What is the current status of trial NCT06325696?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2025-05-05. Estimated completion is 2027-12-31.
What conditions does trial NCT06325696 study?
This clinical trial studies the following conditions: Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease, Lung Diseases, Interstitial.
What interventions are being tested in trial NCT06325696?
The interventions under investigation include: hymecromone (DRUG).
Who is sponsoring clinical trial NCT06325696?
This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 145 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06325696 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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