Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)

• Status: Active, not recruiting
• Trial end date: 2024-08-23
• 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

5. 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 during the screening period, 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

Other protocol inclusion and exclusion criteria may apply.