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

NCT06325696 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 10001577001577-E
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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

Interstitial Lung Disease; Idiopathic Pulmonary Fibrosis; Lung Diseases, Interstitial

Keywords

Pulmonary Fibrosis; Lung disease; Hyaluronan; Drug

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of H01 in reducing serum hyaluronan levels in participants with progressive ILD

  Serum HA levels before and after initiation of treatment with H01 over a period of 12 weeks

Secondary Outcomes (4)

• Evaluate the safety and tolerability of oral H01 in participants with progressive ILD.

  On-going throughout study; each study visit

• Evaluate the change in clinical and functional measures in participants with progressive ILD treated with H01.

  On-going throughout study; each study visit

• Evaluate biomarkers of fibrosis in participants with progressive ILD treated with H01.

  On-going throughout study; each study visit

• Evaluate pharmacokinetic changes from baseline in participants with progressive ILD treated with H01.

  On-going throughout study; each study visit

Study Arms (1)

Treatment

EXPERIMENTAL

Adults, male and female with a diagnosis of interstitial lung disease, take 2 doses of 400 mg H01, morning and evening

Drug: hymecromone

Interventions

hymecromone DRUG

400 mg

Treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Active on lung transplantation list
• On supplemental oxygen at rest
• Evidence of an acute respiratory infection or exacerbation of pulmonary fibrosis
• 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 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.
• 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 UDP-glucuronosyltransferase inhibitors: canagliflozin, temazepam, tacrolimus.

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (1)

NIEHS Clinical Research Unit (CRU)

Research Triangle Park, North Carolina, 27709, United States

RECRUITING

Related Publications (4)

• Garantziotis S, Steele MP, Schwartz DA. Pulmonary fibrosis: thinking outside of the lung. J Clin Invest. 2004 Aug;114(3):319-21. doi: 10.1172/JCI22497.

  PMID: 15286797 BACKGROUND

• Raghu G, Chen SY, Yeh WS, Maroni B, Li Q, Lee YC, Collard HR. Idiopathic pulmonary fibrosis in US Medicare beneficiaries aged 65 years and older: incidence, prevalence, and survival, 2001-11. Lancet Respir Med. 2014 Jul;2(7):566-72. doi: 10.1016/S2213-2600(14)70101-8. Epub 2014 May 27.

  PMID: 24875841 BACKGROUND

• Navaratnam V, Fleming KM, West J, Smith CJ, Jenkins RG, Fogarty A, Hubbard RB. The rising incidence of idiopathic pulmonary fibrosis in the U.K. Thorax. 2011 Jun;66(6):462-7. doi: 10.1136/thx.2010.148031. Epub 2011 Apr 27.

  PMID: 21525528 BACKGROUND

• Lederer DJ, Martinez FJ. Idiopathic Pulmonary Fibrosis. N Engl J Med. 2018 Aug 23;379(8):797-798. doi: 10.1056/NEJMc1807508. No abstract available.

  PMID: 30134133 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Lung Diseases, Interstitial; Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis; Lung Diseases

Interventions

Hymecromone

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Umbelliferones; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Stavros Garantziotis, M.D.

  National Institute of Environmental Health Sciences (NIEHS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 22, 2024
• Study Start: May 5, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02-23

Locations

US (1)