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