Phase 2 Interstitial Lung Disease Trial, Recruiting NCT06325696 Sponsor: National Institute of Environmental Health Sciences (NIEHS) Condition: Interstitial Lung Disease
Back to Interstitial Lung Disease

Phase 2 Interstitial Lung Disease Trial, Recruiting

NCT06325696
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are willing and able to understand and sign a consent form, and able to follow the study requirements
  • You are willing to follow all study procedures and are available for the full length of the study
  • You are male or female and over 18 years old
  • A doctor has diagnosed you with Idiopathic Pulmonary Fibrosis (IPF) or another progressive lung scarring condition (ILD)
  • Your lung function test results meet specific minimum levels — your DLCO is above 30% and your FVC is above 45% (confirm with trial site)
  • If you are of reproductive age and sexually active with a partner of the opposite sex, you must use an approved form of contraception, such as condoms, diaphragm, IUD, or hormonal birth control
  • You agree to follow certain lifestyle guidelines throughout the study

Who may not be able to join:

  • You are currently on the waiting list for a lung transplant
  • You need extra oxygen while resting
  • You currently have an active respiratory infection or a sudden worsening of your lung fibrosis
  • You have been diagnosed with celiac disease, or have a wheat or gluten allergy
  • You have cirrhosis or active liver disease, or your liver function blood test results are more than twice the normal level (confirm with trial site)
  • You have a history of inflammatory bowel disease, trouble swallowing, or a condition that affects the food pipe (such as achalasia)
  • You have significant kidney problems, specifically a kidney function score (eGFR) below 40 ml/min (confirm with trial site)
  • Your heart's electrical activity (measured by an ECG) shows certain abnormalities, including a QTcF reading above 450ms, or other findings that the study doctor considers a safety concern
  • You currently have a problem with alcohol or illegal drug use
  • You are pregnant, breastfeeding, or trying to become pregnant
  • If you can become pregnant, you must use effective birth control (such as an IUD, hormonal implant, birth control pills, injections, patches, or vaginal rings) to participate
  • If you are male and your partner could become pregnant, you must also agree to use effective birth control during the study
  • You have a known allergy to the study drug (hymecromone) or any of its ingredients
  • You regularly take certain medications known to interfere with how the study drug is processed in the body — specifically canagliflozin, temazepam, or tacrolimus
  • The study doctor has concerns that you may not be able to follow the study plan
  • You are currently taking part in another clinical treatment trial for ILD (though you may be eligible 12 weeks after finishing another trial)
  • Your dose of other ILD medications has changed in the 3 months before the study start date
  • You have any physical or mental health condition that the study doctor believes could put you at greater risk of harm

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Stavros Garantziotis, M.D., National Institute of Environmental Health Sciences (NIEHS)

Phone: (855) 696-4347

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
National Institute of Environmental Health Sciences (NIEHS)
Registry
ClinicalTrials.gov
Start date
5 May 2025
Est. completion
31 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

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

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov