A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF10073 After Single and Multiple Doses in Healthy Volunteers and the Effect of Itraconazole on CHF10073 Exposure

NCT06746064 | Completed Phase 1

• 2 other identifiers: CLI-010073AA1-012024-515442-17-00
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to assess the safety and tolerability of single ascending doses of inhaled CHF10073 (Part 1 of the study) and multiple ascending doses of CHF10073 (Part 2 of the study). The study will also evaluate the PK profile of study drug in plasma and urine after single and repeated administrations of CHF10073. In addition, this study will also investigate the metabolites profile of CHF10073 in plasma, urine and faeces (Part 2 of the study) and the PK profile of CHF10073 in the lungs after bronchoalveolar lavage (BAL) (Part 3 of the study). In addition, the effect of multiple doses of itraconazole on the pharmacokinetic profile of CHF10073 will be investigated (Part 4 of the study).

Conditions

Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (16)

• Adverse events and adverse drug reactions

  Through study completion, around 8 weeks in Part 1, from 10 to 13 weeks in Part 2, for about 7-8 weeks in Part 3 and for about 15 up to 17 weeks in Part 4

• Vital signs (Systolic and diastolic Blood Pressure)

  From screening up to 42 days post-dose

• Absolute Values for 12-lead Electrocardiogram (ECG) Recording of HR (heart rate), HR from 0 to 24 hours, hourly HR

  From screening up to 28 days post-dose

• Absolute Values for 12-lead ECGs Recording of Intervals

  Intervals recorded: PR, QRS, QT, QTcF

  From screening up to 28 days post-dose

• Change from Baseline for Post-dose 12-lead ECGs Recording of HR, HR from 0 to 24 hours, hourly HR

  From screening up to 28 days post-dose

• Change from Baseline for Post-dose 12-lead ECGs Recording of Intervals

  Intervals recorded: PR, QRS, QT, QTcF

  From screening up to 28 days post-dose

• Number and percentage of subjects with abnormal actual QTcF (Fridericia-corrected QT Interval).

  Part 1 and 2 only: From screening up to 28 days post-dose

• Number and percentage of subjects with abnormal change from the baseline of QTcF and HR from 0 to 24 hours

  Part 1 and 2 only: From screening up to 28 days post-dose

• Number of subjects and percentages by treatment with abnormal parameters derived from 24h Holter ECG recording (total pauses >2.5 secs, atrial fibrillation and atrial flutter, ventricular runs, PAC burden, PVC burden and aberrant morphologies)

  Part 1 and 2 only: From screening up to 28 days post-dose

• Number of subjects with abnormal blood laboratory test results

  Quantitative laboratory parameters (chemistry and haematology) will be summarised by treatment as absolute value and change from baseline using descriptive statistics.

  From screening up to 28 days post-dose

• Number of subjects with abnormal urine laboratory test results

  From screening up to 28 days post-dose

• Spirometry (FEV1 (Forced exhalation volume in the first second))

  From screening up to 28 days post-dose

• Cough recording: percentage of days with cough episodes during the treatment period

  Part 2 only: From first dosing up to 28 days post-dose

• Cough recording: average VAS (visual analogue scale))

  Part 2 only: From first dosing up to 28 days post-dose

• CHF10073 plasma AUCt (Area Under the Curve from time 0 to time t)

  From first dosing up to 42 days post-dose

• CHF10073 plasma Cmax (Maximum Plasma Concentration)

  From first dosing up to 42 days post-dose

Secondary Outcomes (8)

• CHF10073 plasma AUCinf (Area Under the Curve from time 0 Extrapolated to Infinity)

  From first dosing up to 42 days post-dose

• CHF10073 plasma tmax (Time to Maximum Plasma Concentration)

  From first dosing up to 42 days post-dose

• CHF10073 plasma elimination half-life

  From first dosing up to 42 days post-dose

• CHF10073 plasma apparent clearance (CL/F)

  From first dosing up to 42 days post-dose

• CHF10073 plasma apparent volume of distribution (Vz/F)

  From first dosing up to 42 days post-dose

Study Arms (3)

CHF10073 active

EXPERIMENTAL

Drug: CHF10073 (Part 1 - SAD); Drug: CHF10073 (Part 2 - MAD); Drug: CHF10073 (Part 3); Drug: CHF10073 (Part 4)

placebo

PLACEBO COMPARATOR

Drug: Placebo (Part 1 - SAD); Drug: Placebo (Part 2 - MAD)

CHF10073 + itraconazole

EXPERIMENTAL

Drug: itraconazole (Part 4); Drug: CHF10073 (Part 4)

Interventions

CHF10073 (Part 1 - SAD) DRUG

Single doses of CHF10073 for each cohort

CHF10073 active

Placebo (Part 1 - SAD) DRUG

Single doses of placebo matching CHF10073 for each cohort

placebo

CHF10073 (Part 2 - MAD) DRUG

Multiple doses of CHF10073 for each cohort

CHF10073 active

CHF10073 (Part 3) DRUG

Single dose of CHF10073

CHF10073 active

Placebo (Part 2 - MAD) DRUG

Multiple doses of placebo matching CHF10073 for each cohort

placebo

itraconazole (Part 4) DRUG

Multiple dose of itraconazole in treatment period 2

CHF10073 + itraconazole

CHF10073 (Part 4) DRUG

Single dose of CHF10073 in Treatment Period 1 and 2

CHF10073 + itraconazole; CHF10073 active

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject's written informed consent;
• Healthy male (Part 1 to 4) or female (Part 4) 18-55 years;
• Understanding of the study procedures and the correct use of the inhalers;
• BMI between 18.5 and 30.0 kg/m2;
• Non- or ex-smokers (\<5 pack-years and stopped smoking \>1 year prior to screening);
• Good physical and mental status;
• Vital signs within normal limits; body temperature \<37.5°C;
• lead digitised ECG in triplicate considered as normal;
• Lung function measurements within normal limits;
• Males with pregnant or non-pregnant women of childbearing potential (WOCBP) partners must be willing to use contraception
• Part 4 only: women of non-childbearing potential (WONCBP) or WOCBP with fertile male parters willing to use contraception

You may not qualify if:

• Recent participation in another clinical trial;
• Clinically significant abnormal 24h Holter ECG (Part 1 and 2);
• Clinically relevant and uncontrolled medical disorders ;
• Subjects with history of respiratory diseases ;
• Presence of any current or recent infection;
• Clinically relevant abnormal laboratory values;
• Abnormal liver enzymes;
• Positive results from the Hepatitis serology results;
• Positive HIV-1 or HIV-2 serology results ;
• Recent blood donation or blood loss (≥450 mL) ;
• Heavy caffeine drinker ;
• Recent use of any kind of electronic smoking devices;
• Documented history of alcohol abuse within 12 months prior to screening ;
• Documented history of drug abuse within 12 months prior to screening ;
• Intake of non-permitted concomitant medications ;

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (1)

SGS Belgium NV Clinical Pharmacology Unit

Edegem, 2650, Belgium

Location

MeSH Terms

Conditions

Pulmonary Fibrosis

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Jelle Klein, MD

  SGS Belgium

  PRINCIPAL INVESTIGATOR

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

Model Details: Part 1 - SAD (single ascending dose): Randomised, double-blind, placebo-controlled, single-dose escalation, parallel-group design in HVs. Part 2 - MAD (multiple ascending dose): Randomised, double-blind, placebo-controlled, repeated-dose escalation, parallel-group design in HVs; Part 3: Non-randomised, open-label, single dose design in HVs Part 4 - Non-randomised, open-label, one-sequence, two-period crossover design in HVs.

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 24, 2024
• Study Start: January 13, 2025
• Primary Completion: February 4, 2026
• Study Completion: February 4, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)