Can an inhaled powder stop lung scarring? a safety trial begins

NCT ID NCT07719218

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This phase 1 trial tests whether an inhaled experimental drug called ICF004 is safe and how the body processes it. Healthy Chinese adults aged 18 to 50 will breathe in either a single or multiple doses of ICF004 or a placebo via a dry powder inhaler. The study aims to identify any side effects and measure drug levels in the blood. ICF004 is being developed as a potential future treatment for progressive lung scarring (interstitial lung disease).

What this could mean

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

Active substance
an inhaled experimental drug called ICF004
What this could lead to
If safe, ICF004 could be tested as a treatment for progressive lung scarring (pulmonary fibrosis).
What could go wrong
This is an early phase 1 safety trial in healthy people, not patients. It cannot show whether the drug works for lung disease, and side effects are unknown.

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

About 73 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 50 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: 1. Fully understand the study procedures and methods, volunteer to participate in this study, and sign the written informed consent form. 2. Healthy adult participants, male or female, aged 18 to 50 years (inclusive). 3. Body Mass Index (BMI) ≥ 18 and \< 28 kg/m²; body weight ≥ 50.0 kg and \< 90.0 kg for males, and ≥ 45.0 kg and \< 90.0 kg for females. 4. Medically healthy as determined by the investigator, based on the absence of clinically significant abnormalities in physical examinations, laboratory tests, vital signs, chest X-ray, and electrocardiogram (ECG). 5. Able to use the inhalation device correctly and effectively. 6. Agree to use effective contraceptive measures throughout the study period. Female participants of childbearing potential must agree to use effective contraception from the screening period until 6 months after the last dose. During this period, female participants must agree to have no plans for pregnancy or egg donation/harvesting; male participants must agree to have no plans to father a child or donate sperm. Their male or female partners of childbearing potential must also agree to use effective contraceptive measures during this period. Exclusion Criteria: 1. History of any clinically significant disease (including past and current history), including but not limited to respiratory, cardiovascular, gastrointestinal, hematological, endocrine, immunological, dermatological, malignant tumor, neuropsychiatric, ear/nose/throat (ENT), or metabolic diseases; or any other condition that, in the opinion of the investigator (or sub-investigator), makes the participant unsuitable for the study. 2. Major surgery within 6 months prior to dosing, planned surgery during the study, or previous surgery that may significantly affect the pharmacokinetics or safety evaluation of the study drug. 3. Current oral diseases that may affect the study, as judged by the investigator (e.g., oropharyngeal candidiasis, oral ulcers, oral mucosal lesions). 4. Fever (body temperature \> 37.5°C) or symptomatic respiratory infection within 1 month prior to dosing; any infection requiring systemic antibiotics or antivirals within 3 months prior to screening; or a history of recurrent infections. 5. Positive test results for Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen (HBsAg), Treponema pallidum (syphilis) antibody, or Hepatitis C Virus (HCV) antibody. 6. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), or total bilirubin exceeding the upper limit of normal (ULN) at the screening or baseline visit. 7. Forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) \< 80% of the predicted value, or FEV1/FVC \< 0.7, or arterial oxygen saturation \< 95% at the screening or baseline visit. 8. Smoking (including e-cigarettes) within 6 months prior to dosing, or a positive smoking (nicotine/cotinine) test. 9. History of drug abuse within 3 months prior to screening, or a positive urine drug screen. 10. Participation in any drug or medical device clinical trial within 3 months prior to screening. 11. Blood donation or blood loss ≥ 400 mL within 3 months prior to dosing. 12. Difficulty in venous blood sampling, intolerance to venipuncture, or a history of needle or blood phobia (vasovagal syncope). 13. Known allergy to the study drug or any of its ingredients. 14. Female participants who are pregnant or lactating, or who plan to become pregnant from the time of the study through 6 months after the last dose. 15. Any condition that, in the opinion of the investigator, makes the participant unsuitable for participation in the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  2. A doctor treating you

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