A Study to Evaluate LTI-03 in Newly Diagnosed Idiopathic Pulmonary Fibrosis (IPF) Patients

Korábbi kezelés

• Treatment with an approved or investigational antifibrotic therapy for IPF within 2 months of the Baseline bronchoscopy.
• Use of N-acetyl cysteine or other supplements within 7 days prior to dosing and throughout the Treatment Period.
• Pulmonary exacerbation within 6 months prior to Screening.
• Febrile illness within 7 days prior to dosing.
• Participation in a clinical study or treatment with an investigational drug or device within 30 days of the Screening Visit (or 5 half-lives of the investigational agent, whichever is longer).
• Females of childbearing potential (FOCBP) and men with partners of childbearing potential who do not agree to use an acceptable form of contraception for the duration of study treatment and for at least 90 days after the last dose of study drug. Male subjects who do not agree to refrain from donating sperm during this same period.

Más betegség

• Interstitial lung disease other than IPF.
• Evidence of significant obstructive lung disease.
• Serious or active medical or psychiatric condition which, in the opinion of the Investigator, may interfere with treatment, assessment, or compliance with the protocol.
• Subject has severe progressive or uncontrolled, clinically significant disease that in the judgment of the investigator or designee renders the subject unsuitable for the study.

Laborértékek

• History or evidence at screening of significant renal impairment with eGFR < 30 mL/min (region specific).
• History or evidence at screening of significant hepatic impairment with bilirubin > 3 mg/dL (> 51.3 µmol/L) and albumin < 2.8 g/dL (<28 g/L) and PT prolongation > 6 sec or INR > 2.3 (region specific).

Egyéb

• Current diagnosis of asthma.
• Inability to use study inhaler device appropriately.
• Vaccination within 2 weeks of start of dosing (Day 1) and throughout the Treatment Period.
• Positive urine pregnancy test in female subjects of childbearing potential as defined below.
• Female subjects who are lactating.

• Male or female subject of age 40 years or older.
• Willing and able to provide written informed consent.
• Diagnosis of IPF within 3 years of Screening as confirmed by HRCT of chest or lung biopsy as defined by ATS/ERS/JRS/ALAT guideline.
• Forced vital capacity (FVC) percent predicted ≥ 40%.
• Diffusion capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥ 30 and ≤ 80.
• Forced expiratory volume 1 (FEV1)/FVC ≥ 0.7.