Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis

• Status: Recruiting
• Trial end date: 2026-02-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: InSilico Medicine Hong Kong Limited

Criteria

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. 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:

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