NCT05975983 · InSilico Medicine Hong Kong Limited
Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis
What this study is about
The goal of this clinical trial is to learn about INS018\_055 in adults with Idiopathic Pulmonary Fibrosis (IPF). The primary objective is to evaluate the safety and how well patients handle the treatment of INS018\_055 taken by mouth administered for up to 12 weeks in adult subjects with IPF compared to placebo.
View original scientific description
The goal of this clinical trial is to learn about INS018\_055 in adults with Idiopathic Pulmonary Fibrosis (IPF). The primary objective is to evaluate the safety and tolerability of INS018\_055 orally administered for up to 12 weeks in adult subjects with IPF compared to placebo.
Interventions
DRUG
INS018_055
Pharmaceutical formulation: Tablet Mode of Administration: Oral
DRUG
Placebo
Pharmaceutical formulation: Tablet Mode of Administration: Oral
Primary outcome measures
Percentage of subjects who have at least 1 treatment-emergent adverse event (TEAE)
Time frame: Day 1 (Visit 2) up to Week 12 (End of Treatment (EOT))
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 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
- Acute IPF exacerbation within 4 months prior to Visit 1 and/or Day 1, as determined b
Where
- Birmingham, Alabama
- Scottsdale, Arizona
- Los Angeles, California
- Celebration, Florida
- Orlando, Florida
- Winston-Salem, North Carolina
- Oklahoma City, Oklahoma
- Philadelphia, Pennsylvania
- Columbia, South Carolina
- Dallas, Texas
- McKinney, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 12, 2025 · Source of record for eligibility and locations