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New pill for scarred lungs shows promise in early trial

NCT ID NCT05938920

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested an experimental oral drug called INS018_055 in 71 adults with idiopathic pulmonary fibrosis (IPF), a disease that causes lung scarring and makes breathing hard. The main goal was to see if the drug is safe and tolerable over 12 weeks compared to a placebo. Researchers also measured lung function changes. The trial has been completed.

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

71 people

The number who actually took part.

Started

Jun 2023

Finished

Aug 2024

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. Subjects with background pirfenidone or nintedanib may be enrolled if their regimen of antifibrotic therapy has been stable for \> 8 weeks prior to Visit 1 5. Meeting all of the following criteria during the screening period: 1. FVC ≥40% predicted of normal 2. DLCO corrected for Hgb ≥25% and \<80% predicted of 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 during the screening period, 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 Other protocol inclusion and exclusion criteria may apply.

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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)

Contacts and locations

Locations

  • Anhui Chest Hospital

    Hefei, Anhui, 230031, China

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050, China

  • General Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300052, China

  • Hainan General Hospital

    Haikou, Hainan, 570311, China

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330006, China

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515, China

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008, China

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100730, China

  • Peking University Shougang Hospital

    Beijing, Beijing Municipality, 100041, China

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250013, China

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030, China

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 201800, China

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030032, China

  • The First Affiliated Hospital - Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310006, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052, China

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510080, China

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230601, China

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011, China

  • The Shengjing Hospital of China medical university

    Shenyang, Liaoning, 110004, China

  • The West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041, China

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008, China

  • Zhongshan hospital Fudan University

    Shanghai, Shanghai Municipality, 200032, China

More trials for these conditions

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