Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis
InSilico Medicine Hong Kong Limited · NCT05975983
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 40+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 40
- US sites recruiting
- 12
- Study start
- February 8, 2024
- Record last updated
- November 12, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
The purpose of this revised Phase IIa study is to demonstrate safety of INS018_055 over 12 weeks in adults with Idiopathic Pulmonary Fibrosis (IPF).
Being studied: INS018_055; Placebo
Conditions: Idiopathic Pulmonary Fibrosis (IPF)
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Male or female patients aged ≥40 years based on the date of the written informed consent form
- Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines
- 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
- Meeting all of the following criteria during the screening period:
- FVC ≥40% predicted normal
- DLCO corrected for Hgb ≥25% and \<80% predicted normal
- 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 by the investigator
- Patients who are unwilling to refrain from smoking within 3 months prior to screening and until the end of the study
- Female patients who are pregnant or nursing
- Abnormal ECG findings
Recruiting US locations
University of Alabama at Birmingham
Birmingham, AL 35294
HonorHealth Research Institute
Scottsdale, AZ 85258
Keck School of Medicine of USC
Los Angeles, CA 90033
Florida Lung Asthma and Sleep Specialist
Celebration, FL 34747-1818
Central Florida Pulmonary Group, P.A. (CFPG) - Downtown Orlando
Orlando, FL 32803-5727
Southeastern Research Center
Winston-Salem, NC 27103-4007
University of Oklahoma Health Sciences Center (OUHSC)
Oklahoma City, OK 73104-5417
Temple University Hospital-Temple Lung Center
Philadelphia, PA 19140
Bogan Sleep Consultants, LLC
Columbia, SC 29201-2953
University of Texas Southwestern Medical Center
Dallas, TX 75235-6243
Metroplex Pulmonary and Sleep Center
McKinney, TX 75069-1898
Research Centers of America
McKinney, TX 75071
Study contacts (from the official record)
- Monique Duncan · +86 18817554306 · Insilico-Clinicaltrial@insilico.ai
- Carol Salter, MD, PhD · Insilico-Clinicaltrial@insilico.ai