Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorInSilico Medicine Hong Kong Limited

About this trial

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 criteria

Qualifiers

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

FVC ≥40% predicted normal

Disqualifiers

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

Trial design

Treatments tested in this trial

  • INS018_055
  • Placebo

Treatment groups

40 Participants
are divided into 2 treatment groups

Locations

12
Alabama
University of Alabama at Birmingham35294, Birmingham United States
Arizona
HonorHealth Research Institute85258, Scottsdale United States
California
Keck School of Medicine of USC90033, Los Angeles United States
Florida
Florida Lung Asthma and Sleep Specialist34747-1818, Celebration United States

Sponsors and collaborators

InSilico Medicine Hong Kong Limited

Lead sponsor