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Not Yet Recruiting NCT07876284

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

Conditions: Idiopathic Pulmonary Fibrosis

Sex: All
Ages: 40 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 18
Sponsor: Chiesi Farmaceutici S.p.A.

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.

Eligibility 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07876284). StuddyBuddy aggregates publicly available trial information.