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Clinical Trials in the USA / NCT05975983
Recruiting Phase 2

Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

NCT05975983 · tracked via the Priya Life Science USA tracker
Sponsor
InSilico Medicine Hong Kong Limited
Phase
Phase 2
Started
2024-02-08
Last updated
2025-11-12

Condition(s) studied

Idiopathic Pulmonary Fibrosis (IPF)

Investigational drug(s) / intervention(s)

INS018_055Placebo

INS018_055: Pharmaceutical formulation: Tablet Mode of Administration: Oral

Placebo: Pharmaceutical formulation: Tablet Mode of Administration: Oral

Study summary

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).

Eligibility

Sex
ALL
Min age
40 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Recruiting
HonorHealth Research Institute Scottsdale Arizona Recruiting
Keck School of Medicine of USC Los Angeles California Recruiting
Florida Lung Asthma and Sleep Specialist Celebration Florida Recruiting
Central Florida Pulmonary Group, P.A. (CFPG) - Downtown Orlando Orlando Florida Recruiting
Southeastern Research Center Winston-Salem North Carolina Recruiting
University of Oklahoma Health Sciences Center (OUHSC) Oklahoma City Oklahoma Recruiting
Temple University Hospital-Temple Lung Center Philadelphia Pennsylvania Recruiting
Bogan Sleep Consultants, LLC Columbia South Carolina Recruiting
University of Texas Southwestern Medical Center Dallas Texas Recruiting
Metroplex Pulmonary and Sleep Center McKinney Texas Recruiting
Research Centers of America McKinney Texas Recruiting

More InSilico Medicine Hong Kong Limited trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05975983 on ClinicalTrials.gov ↗ ← All trials in the USA