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New inhaled drug tested in healthy volunteers for lung scarring disease

NCT ID NCT06746064

Knowledge-focused Sponsor: Chiesi Farmaceutici S.p.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested the safety and how the body handles an inhaled drug called CHF10073 in 155 healthy volunteers. The drug is being developed for pulmonary fibrosis, a serious lung-scarring condition. The trial looked at different single and multiple doses, and also checked how another drug (itraconazole) affects CHF10073 levels. Since this is a Phase 1 study in healthy people, it does not test if the drug actually treats the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CHF10073 (inhaled drug)
What this could lead to
If successful, this could support further testing of CHF10073 as a potential treatment for pulmonary fibrosis.
What could go wrong
This is a very early Phase 1 study in healthy people, not patients. It only checks safety and drug levels, not whether the drug works for the disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

155 people

The number who actually took part.

Started

Jan 2025

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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; * 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 Exclusion Criteria: * 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 ; * 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

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Conditions

The condition(s) this trial relates to.

pulmonary fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary fibrosis

Contacts and locations

Locations

  • SGS Belgium NV Clinical Pharmacology Unit

    Edegem, 2650, Belgium

More trials for these conditions

Other studies related to the condition(s) this trial covers.