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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: Recruiting Phase 2 study of Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease, sponsored by National Institute of Environmental Health Sciences (NIEHS).
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What NCT06325696 shows while recruiting
NCT06325696 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 751-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (95% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06325696's enrollment target sits among peer trials
37 36th of 51 higher than 16 of 51 other Idiopathic Pulmonary Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Idiopathic Pulmonary Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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