RECRUITING

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

Conditions

Interstitial Lung Disease Idiopathic Pulmonary Fibrosis Lung Diseases, Interstitial Pulmonary Fibrosis Lung disease Hyaluronan Drug

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-03-10

Study Completion:2027-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06325696

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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% \<80%, FVC\>45% and \<80% * 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	* Active on lung transplantation list * On supplemental oxygen at rest * Evidence of an acute respiratory infection or exacerbation of pulmonary fibrosis at any time during enrollment or study * Known diagnosis of celiac disease or wheat or gluten allergies * 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 history of active Inflammatory Bowel Disease, dysphagia, achalasia, or difficulty swallowing capsules, tablets or pills * Subjects with significant renal impairment defined as eGFR lower than 60 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. * Subjects with ongoing alcohol or illegal drug use disorder * 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. * Known allergy to hymecromone or any component thereof * Chronic therapy with medications that are known potent human UDPglucuronosyltransferase inhibitors: canagliflozin, temazepam, tacrolimus. * 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. * 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.

Inclusion Criteria

Exclusion 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% \<80%, FVC\>45% and \<80%
* 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

* Active on lung transplantation list
* On supplemental oxygen at rest
* Evidence of an acute respiratory infection or exacerbation of pulmonary fibrosis at any time during enrollment or study
* Known diagnosis of celiac disease or wheat or gluten allergies
* 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 history of active Inflammatory Bowel Disease, dysphagia, achalasia, or difficulty swallowing capsules, tablets or pills
* Subjects with significant renal impairment defined as eGFR lower than 60 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.
* Subjects with ongoing alcohol or illegal drug use disorder
* 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.
* Known allergy to hymecromone or any component thereof
* Chronic therapy with medications that are known potent human UDPglucuronosyltransferase inhibitors: canagliflozin, temazepam, tacrolimus.
* 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.
* 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.

Contacts and Locations

Study Contact

NIEHS Join A Study Recruitment Group

CONTACT

(855) 696-4347

myniehs@nih.gov

Stavros Garantziotis, M.D.

CONTACT

(984) 287-4412

garantziotis@mail.nih.gov

Principal Investigator

Stavros Garantziotis, M.D.

PRINCIPAL_INVESTIGATOR

National Institute of Environmental Health Sciences (NIEHS)

Study Locations (Sites)

NIEHS Clinical Research Unit (CRU)

Research Triangle Park, North Carolina, 27709

United States

Collaborators and Investigators

Sponsor: National Institute of Environmental Health Sciences (NIEHS)

Stavros Garantziotis, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Environmental Health Sciences (NIEHS)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-10

Study Completion Date2027-12-31

Study Record Updates

Study Start Date2025-03-10

Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

Pulmonary Fibrosis
Lung disease
Hyaluronan
Drug

Additional Relevant MeSH Terms

Interstitial Lung Disease
Idiopathic Pulmonary Fibrosis
Lung Diseases, Interstitial