Idiopathic Pulmonary FibrosisPhase 1NCT07876284
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Repeated Doses of Inhaled CHF10073 in Participants With Idiopathic Pulmonary Fibrosis
A Phase 1 study testing CHF10073 low dose and CHF10073 high dose in people with Idiopathic Pulmonary Fibrosis, run by Chiesi Farmaceutici S.p.A..
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- CHF10073 low dose and CHF10073 high dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Aug 2027
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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
Who cannot join
- 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.
Show all 23Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Repeated Doses of Inhaled CHF10073 in Participants With Idiopathic Pulmonary Fibrosis (IPF)
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
- Being tested
- CHF10073 low dose, CHF10073 high dose, Placebo
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHF10073 low doseDrug
Multiple doses of CHF10073
CHF10073 high doseDrug
Multiple doses of CHF10073
PlaceboDrug
Multiple doses of placebo
| Study group | Role | What they receive |
|---|---|---|
| CHF10073 low dose | Experimental | Not described Receives: Drug: CHF10073 low dose |
| CHF10073 high dose | Experimental | Not described Receives: Drug: CHF10073 high dose |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 through Follow-up visit, 35 to 42 days after the last dose
Change from baseline in systolic and diastolic blood pressure
Measured: Day 1, Day 14 and Day 28 at pre-dose and 3 hours post-dose
Change from baseline in pulse rate
Measured: Day 1, Day 14 and Day 28 at pre-dose and 3 hours post-dose
Change from baseline in respiratory rate
Measured: Day 1, Day 14 and Day 28 at pre-dose and 3 hours post-dose
Change from baseline in body temperature
Measured: Day 1, Day 14 and Day 28 at pre-dose and 3 hours post-dose
Change from baseline in oxygen saturation
Measured: 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.
Measured: Day 1 through Follow-up visit, 35 to 42 days after the last dose
Change from baseline in ECG heart rate
Measured: 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 and QT interval corrected using Fridericia's formula.
Measured: 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: QRS duration
Measured: 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.
Measured: 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
Measured: 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
Quantitative laboratory parameters (chemistry and haematology) will be summarised by treatment as absolute value and change from baseline using descriptive statistics.
Measured: Day 1, Day 14 and Day 28 at pre-dose
Change from baseline in forced vital capacity and forced expiratory volume in 1 second.
Measured: Day 1 , Day 14 and Day 28 at pre-dose and 30 minutes post-dose
Secondary outcomes (6)
Number and percentage of participants experiencing cough treatment-emergent adverse events
Measured: Day 1 through Follow-up visit, 35 to 42 days after the last dose
Plasma pharmacokinetic parameter AUC0-t for CHF10073.
Measured: Day 1 and Day 28
Maximum observed plasma concentration (Cmax) of CHF10073.
Measured: Day 1 and Day 28
Time to reach maximum observed plasma concentration (tmax) of CHF10073
Measured: Day 1 and Day 28
Dose proportionality assessment using dose-normalized, log-transformed AUC0-t and Cmax as applicable.
Measured: Day 1 and Day 28
Plasma concentration-time profiles summarized by dose level and study day
Measured: Day 1, Day 14, Day 28, and Follow-up, 35 to 42 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pilar Rivera Ortega, MD, Principal investigator, Royal Devon and Exeter Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876284
- Sponsor's protocol ID
- CLI-010073AA1-02
- Other IDs
- 2026-526678-18-00
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Chiesi clinical data sharing scope, process and data access criteria is available on the Chiesi Group website.