A Study to Assess the Safety, Tolerability and Pharmacokinetics of Repeated Doses of Inhaled CHF10073 in Participants With Idiopathic Pulmonary Fibrosis

Study Identifier:
CLI-010073AA1-02
ClinicalTrials.gov Identifier:
NCT07876284
EudraCT Identifier:
N/A
EU CT ID:
2026-526678-18-00
Study Contact Information:
+39 0521 2791 or [email protected]
Will Be Recruiting

Study Details

Medical Condition
  • Idiopatic Pulmonary Fibrosis
Study Drug
  • Drug: CHF10073 low dose
  • Drug: CHF10073 high dose
  • Drug: Placebo
Date
Nov 2026 - Aug 2027
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 40+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Written informed consent obtained before any study-related procedure.
  • Male or female participant of any race, aged 40 years or older.
  • Diagnosis of idiopathic pulmonary fibrosis according to the 2018 and 2022 ATS/ERS/JRS/ALAT Guidelines for no more than 8 years before Screening, confirmed by centrally reviewed high-resolution computed tomography obtained within 12 months before Screening or performed during Screening.
  • Receiving locally approved idiopathic pulmonary fibrosis monotherapy at a stable dose for at least 8 weeks before Screening, or not receiving such monotherapy, including discontinuation at least 4 weeks before Screening.
  • Forced vital capacity at least 45% predicted and pre-bronchodilator forced expiratory volume in 1 second/forced vital capacity ratio at least 0.7.
  • Diffusing capacity of the lung for carbon monoxide, corrected for hemoglobin, at least 25% predicted.
  • Peripheral oxygen saturation greater than 90% after 5 minutes at rest on room air or with protocol-specified supplemental oxygen.
  • Ability to correctly use the device after training with placebo.
  • Nonsmoker or ex-smoker meeting protocol-defined cessation periods and willing to abstain from all inhaled smoking products throughout the study.
  • Female participant meeting protocol definitions for non-childbearing potential or, if of childbearing potential, meeting pregnancy-testing and contraception requirements.
  • Male participant meeting protocol-defined fertility and contraception requirements
Exclusion Criteria
  • Lower respiratory tract infection requiring antibiotics within 4 weeks before Screening or documented acute exacerbation of idiopathic pulmonary fibrosis within 3 months before Screening.
  • Planned major surgery during the study or history of lung resection.
  • Active or prior lung cancer.
  • Active cancer or cancer history with less than 5 years disease-free survival, except adequately treated localized carcinoma.
  • Emphysema involving at least 50% of the lung on high-resolution computed tomography or emphysema greater in extent than fibrosis.
  • End-stage fibrotic disease expected to require organ transplantation within 6 months.
  • Clinically relevant uncontrolled medical or psychiatric disorders that may interfere with study completion or increase risk.
  • Other non-idiopathic pulmonary fibrosis pulmonary condition that may affect forced vital capacity.
  • Body mass index reater than or equal to 35.0 kg/m² or recent excessive unexplained weight loss.
  • Clinically significant abnormal 12-lead electrocardiogram; corrected QT interval using Fridericia's formula greater than 450 milliseconds for males or greater than 470 milliseconds for females.
  • Clinically significant cardiovascular condition that would preclude participation.
  • Significant neurologic disease, including protocol-specified recent transient ischemic attack, stroke, seizure, uncontrolled seizure disorder, or clinically significant behavioral or psychiatric disturbance.
  • Recent or current systemic corticosteroid, immunosuppressant, cytotoxic therapy, pulmonary hypertension vasodilator therapy, inhaled bronchodilator, or inhaled corticosteroid use within protocol-specified periods.
  • Concomitant treatment with more than one locally approved idiopathic pulmonary fibrosis therapy.
  • Participation in another investigational drug trial within 3 months or 5 half-lives of that drug, whichever is longer.
  • New or unresolved infection within 7 days before Screening or randomization, except respiratory infections addressed separately.
  • Known intolerance or hypersensitivity to formulation excipients or another substance used in the trial.
  • Use of non permitted concomitant medication as per protocol.
  • Clinically relevant abnormal laboratory values requiring investigation or potentially affecting safety or study evaluation.
  • Positive human immunodeficiency virus type 1 or type 2 test at Screening.
  • Positive hepatitis test indicating acute or chronic hepatitis B or C at Screening.
  • Documented alcohol or drug abuse within 12 months before Screening.
  • Pregnant or lactating female participant.
Healthy Volunteers
No

Protocol Summary

The objective of the study is to assess the safety and tolerability of repeated doses of CHF10073 and to characterise cough-related safety outcomes associated with CHF10073 administration. In addition, the study will also characterise the PK (pharmacokinetics) profile in plasma after repeated administrations of study drug.

Study Locations

No locations found.