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

NCT07876284 | Not Yet Recruiting Phase 1

• 2 other identifiers: CLI-010073AA1-022026-526678-18-00
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (12)

• Number and % of participants with treatment-emergent adverse events, adverse drug reactions, serious and non-serious events, related and non-related events, severe events, events leading to discontinuation and events leading to death

  Day 1 through Follow-up visit, 35 to 42 days after the last dose

• Change from baseline in systolic and diastolic blood pressure

  Day 1, Day 14 and Day 28 at pre-dose and 3 hours post-dose

• Change from baseline in pulse rate, respiratory rate

  Day 1, Day 14 and Day 28 at pre-dose and 3 hours post-dose

• Change from baseline in body temperature

  Day 1, Day 14 and Day 28 at pre-dose and 3 hours post-dose

• Change from baseline in oxygen saturation

  Day 1, Day 14 and Day 28 at pre-dose and 3 hours post-dose

• Number and percentage of participants with a change from baseline greater than 20 mmHg in systolic blood pressure and greater than 10 mmHg in diastolic blood pressure.

  Day 1 through Follow-up visit, 35 to 42 days after the last dose

• Change from baseline in ECG heart rate

  Day 1, Day 14 and Day 28 at pre-dose and at 3 hours post-dose (up to Follow-up visit, 35 to 42 days after the last dose for UK)

• Change from baseline in ECG intervals: PR interval, QRS duration, and QT interval corrected using Fridericia's formula.

  Day 1, Day 14 and Day 28 at pre-dose and at 3 hours post-dose (up to Follow-up visit, 35 to 42 days after the last dose for UK)

• Number and percentage of participants with an increase from baseline in QT interval corrected using Fridericia's formula greater than 30 milliseconds and greater than 60 milliseconds.

  Day 1 through Day 28 (up to Follow-up visit, 35 to 42 days after the last dose for UK)

• Number and percentage of male participants with post-dose QT interval corrected using Fridericia's formula greater than 450, 480, and 500 milliseconds and female participants with values greater than 470 and 500 milliseconds

  Day 1 through Day 28 (up to Follow-up visit, 35 to 42 days after the last dose for UK)

• Change and shift from baseline in clinical chemistry, including fasting glucose, and hematology evaluations

  Day 1, Day 14 and Day 28 at pre-dose

• Change from baseline in forced vital capacity and forced expiratory volume in 1 second.

  Day 1 , Day 14 and Day 28 at pre-dose and 30 minutes post-dose

Secondary Outcomes (6)

• Number of cough events and number and percentage of participants experiencing cough treatment-emergent adverse events

  Day 1 through Follow-up visit, 35 to 42 days after the last dose

• Plasma pharmacokinetic parameter AUC0-t for CHF10073.

  Day 1 and Day 28

• Maximum observed plasma concentration (Cmax) of CHF10073.

  Day 1 and Day 28

• Time to reach maximum observed plasma concentration (tmax) of CHF10073

  Day 1 and Day 28

• Dose proportionality assessment using dose-normalized, log-transformed AUC0-t and Cmax as applicable.

  Day 1 and Day 28

Study Arms (3)

CHF10073 low dose

EXPERIMENTAL

Drug: CHF10073 low dose

CHF10073 high dose

EXPERIMENTAL

Drug: CHF10073 high dose

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CHF10073 low dose DRUG

Multiple doses of CHF10073

CHF10073 low dose

CHF10073 high dose DRUG

Multiple doses of CHF10073

CHF10073 high dose

Placebo DRUG

Multiple doses of placebo

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Pilar Rivera Ortega, MD

  Royal Devon and Exeter Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiesi Clinical Trial info

CONTACT

+39 0521 2791; clinicaltrials_info@chiesi.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2026
• First Posted: October 15, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share