NCT06325696RecruitingPhase 2
H01 in Adults With Interstitial Lung Disease (The SOLIS Study)
Phase IIa Investigation of H01 in Adults With Interstitial Lung Disease (The SOLIS Study)
Source: ClinicalTrials.gov · Last updated 28 Jul 2026
Brief summary (registry, in English)
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. Participants who decide to continue longer may enter an optional 12 week extension phase, for a maximum treatment time of 24 weeks. Tests will be repeated at study visits.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 37 (estimated)
- First submitted
- 21 Mar 2024
- Start date
- 5 May 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Diseases
- Idiopathic pulmonary fibrosis
- NCT number
- NCT06325696
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 37
- From 5 May 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active on lung transplantation list
- Subjects who are pregnant, lactating or attempting to conceive
- Participants able to become pregnant (have not completed menopause, had a hysterectomy and/or both tubes and/or both ovaries removed) must use effective birth control methods to try and not become pregnant while participant in this study. Methods include (a) partner vasectomy, (b) bilateral tubal ligation, (c) intrauterine devices (IUDs), (d) hormonal implants (such as Implanon), or (e) other hormonal methods (birth control pills, injections, patches, vaginal rings).
- Male participants able to father children with a partner able to become pregnant must agree to use effective birth control (listed above) to participate in this study.
- Chronic therapy with medications that are known potent human UDP-glucuronosyltransferase inhibitors: canagliflozin, temazepam, tacrolimus.
- Changing dose of other ILD medications over the 3 months prior to baseline
- Any condition(s) or diagnosis, both physical or psychological, or physical exam finding that place the participant at increased risk for adverse effects, as determined by the study physician.
- Participants who completed the original 12-week treatment portion of the SOLIS study prior to the implementation of the optional 12-week extension phase may have the option to re-enroll under the amended protocol, after an appropriate washout period of up to 6 months. Participants will be re-screened as per criteria above to ensure that eligibility criteria continue to be met. Once eligibility is confirmed, participants can complete the 12-week treatment and optional 12-week extension for a maximum treatment period of 24 weeks. These re-enrolled participants will be enrolled as new participants and receive a different screening number to differentiate them from the original enrollment.
Other illness
- Evidence of an acute respiratory infection or exacerbation of pulmonary fibrosis
- Known diagnosis of celiac disease or wheat or gluten allergies
- Subjects with history of active Inflammatory Bowel Disease, dysphagia, achalasia, or difficulty swallowing capsules, tablets or pills
- Subjects with ongoing alcohol or illegal drug use disorder
- Known allergy to hymecromone or any component thereof
Lab values
- Cirrhosis or active viral or non-viral hepatitis: Bilirubin, AST and ALT values higher than twice the upper range of normal, or a Child-Pugh score of 7 or more
- Subjects with significant renal impairment defined as eGFR lower than 40 ml/min.
- Subjects with a baseline corrected Fridericia's QT interval (QTcF) \>450ms or baseline ECG abnormalities which, in the opinion of the study physician, are clinically significant and would place the participant at increased risk for adverse effects.
Other
- An individual who meets any of the following criteria will be excluded from participation in this study:
- On supplemental oxygen at rest
- Physician concern that participant may not adhere to the study protocol
- Current participation in another clinical treatment trial for ILD. May participate after 12 weeks from conclusion of another treatment trial.
Criteria the registry did not label
- INCLUSION CRITERIA:
- 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
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NIEHS Clinical Research Unit (CRU) Coordinator of this site? Confirm its status | Research Triangle Park | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.