Pulmonary FibrosisPhase 1NCT06746064
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
A Phase 1 study testing CHF10073 (Part 1 - SAD), CHF10073 (Part 2 - MAD) and CHF10073 (Part 3) in people with Pulmonary Fibrosis, run by Chiesi Farmaceutici S.p.A. at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Fibrosis
- What is being tested?
- CHF10073 (Part 1 - SAD), CHF10073 (Part 2 - MAD) and CHF10073 (Part 3)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Jan 2025to 4 Feb 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Show all 11Show fewer
- Vital signs within normal limits; body temperature <37.5°C;
- 12-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
Who cannot join
- 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;
Show all 21Show fewer
- 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 ;
- Known intolerance and/or hypersensitivity to any of the study excipients ;
- Unsuitable veins for repeated venipuncture;
- Part 3 only: contraindication to the BAL procedure;
- Part 3 only: recent lower respiratory tract infections
- Part 4 only: known allergy to antifungal medicines;
- Part 4 and females only: pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of CHF10073 After Single and Multiple Ascending Doses in Healthy Volunteers Via Inhalation and the Effect of Multiple Doses of Itraconazole on CHF10073 Exposure
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
- Being tested
- CHF10073 (Part 1 - SAD), Placebo (Part 1 - SAD), CHF10073 (Part 2 - MAD), CHF10073 (Part 3), Placebo (Part 2 - MAD)
- Medical subject headings
- Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHF10073 (Part 1 - SAD)Drug
Single doses of CHF10073 for each cohort
Placebo (Part 1 - SAD)Drug
Single doses of placebo matching CHF10073 for each cohort
CHF10073 (Part 2 - MAD)Drug
Multiple doses of CHF10073 for each cohort
CHF10073 (Part 3)Drug
Single dose of CHF10073
Placebo (Part 2 - MAD)Drug
Multiple doses of placebo matching CHF10073 for each cohort
itraconazole (Part 4)Drug
Multiple dose of itraconazole in treatment period 2
CHF10073 (Part 4)Drug
Single dose of CHF10073 in Treatment Period 1 and 2
| Study group | Role | What they receive |
|---|---|---|
| CHF10073 active | Experimental | Not described Receives: Drug: CHF10073 (Part 1 - SAD); Drug: CHF10073 (Part 2 - MAD); Drug: CHF10073 (Part 3); Drug: CHF10073 (Part 4) |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo (Part 1 - SAD); Drug: Placebo (Part 2 - MAD) |
| CHF10073 + itraconazole | Experimental | Not described Receives: Drug: itraconazole (Part 4); Drug: CHF10073 (Part 4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events and adverse drug reactions
Measured: 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)
Measured: 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
Measured: From screening up to 28 days post-dose
Absolute Values for 12-lead ECGs Recording of Intervals
Intervals recorded: PR, QRS, QT, QTcF
Measured: 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
Measured: 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
Measured: From screening up to 28 days post-dose
Number and percentage of subjects with abnormal actual QTcF (Fridericia-corrected QT Interval).
Measured: 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
Measured: 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)
Measured: 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.
Measured: From screening up to 28 days post-dose
Number of subjects with abnormal urine laboratory test results
Measured: From screening up to 28 days post-dose
Spirometry (FEV1 (Forced exhalation volume in the first second))
Measured: From screening up to 28 days post-dose
Cough recording: percentage of days with cough episodes during the treatment period
Measured: Part 2 only: From first dosing up to 28 days post-dose
Cough recording: average VAS (visual analogue scale))
Measured: 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)
Measured: From first dosing up to 42 days post-dose
CHF10073 plasma Cmax (Maximum Plasma Concentration)
Measured: 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)
Measured: From first dosing up to 42 days post-dose
CHF10073 plasma tmax (Time to Maximum Plasma Concentration)
Measured: From first dosing up to 42 days post-dose
CHF10073 plasma elimination half-life
Measured: From first dosing up to 42 days post-dose
CHF10073 plasma apparent clearance (CL/F)
Measured: From first dosing up to 42 days post-dose
CHF10073 plasma apparent volume of distribution (Vz/F)
Measured: From first dosing up to 42 days post-dose
CHF10073 urine amount excreted (Ae)
Measured: Part 1, 2 and 4 : From first dosing up to 28 days post-dose
CHF10073 urine faction excreted (fe)
Measured: Part 1, 2 and 4: From first dosing up to 28 days post-dose
CHF10073 renal clearance (CLr)
Measured: Part 1, 2 and 4: From first dosing up to 28 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start13 Jan 2025
- Primary completion4 Feb 2026
- Study completion4 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jelle Klein, MD, Principal investigator, SGS Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746064
- Sponsor's protocol ID
- CLI-010073AA1-01
- Other IDs
- 2024-515442-17-00
- Status last verified
- Feb 2026
- First submitted
- 26 Nov 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No