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New pill for scarred lungs enters human testing

NCT ID NCT05975983

Disease control Sponsor: InSilico Medicine Hong Kong Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests an experimental oral drug called INS018_055 in 40 adults with idiopathic pulmonary fibrosis (IPF), a disease that causes lung scarring and breathing difficulty. The main goal is to check the drug's safety over 12 weeks. Participants will be randomly assigned to receive either the drug or a placebo, and researchers will also measure how the drug moves through the body.

What this could mean

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

Active substance
INS018_055 (an oral tablet)
What this could lead to
If successful, this could point toward a new oral treatment option for idiopathic pulmonary fibrosis, a serious lung disease with limited therapies.
What could go wrong
This is an early Phase IIa trial with only 40 participants, focused mainly on safety. It is too small and short (12 weeks) to prove the drug works, and many promising drugs fail in later stages.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

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

Started

Feb 2024

Expected to finish

Feb 2026

An estimate. End dates often move.

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

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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. Male or female patients aged ≥40 years based on the date of the written informed consent form 2. Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines 3. In a stable condition and suitable for study participation based on the results of medical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluation 4. Meeting all of the following criteria during the screening period: 1. FVC ≥40% predicted normal 2. DLCO corrected for Hgb ≥25% and \<80% predicted normal 3. Forced Expiratory Volume in the first second/FVC (FEV1/FVC) ratio \>0.7 based on pre-bronchodilator value Exclusion Criteria: 1. Acute IPF exacerbation within 4 months prior to Visit 1 and/or Day 1, as determined by the investigator 2. Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study 3. Female patients who are pregnant or nursing 4. Abnormal ECG findings

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Conditions

The condition(s) this trial relates to.

Fibrosis idiopathic pulmonary fibrosis interstitial lung disease lung disorder Pathologic Processes pulmonary fibrosis respiratory system disorder

As listed by the trial registrant

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

Idiopathic pulmonary fibrosis (IPF)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

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

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bogan Sleep Consultants, LLC

    RECRUITING

    Columbia, South Carolina, 29201-2953, United States

  • Central Florida Pulmonary Group, P.A. (CFPG) - Downtown Orlando

    RECRUITING

    Orlando, Florida, 32803-5727, United States

  • Florida Lung Asthma and Sleep Specialist

    RECRUITING

    Celebration, Florida, 34747-1818, United States

  • HonorHealth Research Institute

    RECRUITING

    Scottsdale, Arizona, 85258, United States

  • Keck School of Medicine of USC

    RECRUITING

    Los Angeles, California, 90033, United States

  • Metroplex Pulmonary and Sleep Center

    RECRUITING

    McKinney, Texas, 75069-1898, United States

  • Research Centers of America

    RECRUITING

    McKinney, Texas, 75071, United States

  • Southeastern Research Center

    RECRUITING

    Winston-Salem, North Carolina, 27103-4007, United States

  • Temple University Hospital-Temple Lung Center

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • University of Oklahoma Health Sciences Center (OUHSC)

    RECRUITING

    Oklahoma City, Oklahoma, 73104-5417, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75235-6243, United States

More trials for these conditions

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