Study Evaluating INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis
A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of INS018_055 Administered Orally to Subjects With Idiopathic Pulmonary Fibrosis (IPF)
InSilico Medicine Hong Kong Limited
40 participants
Feb 8, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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
- Meeting all of the following criteria during the screening period:
- FVC ≥40% predicted normal
- DLCO corrected for Hgb ≥25% and <80% predicted normal
- Forced Expiratory Volume in the first second/FVC (FEV1/FVC) ratio >0.7 based on pre-bronchodilator value
Exclusion Criteria4
- 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
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Interventions
Pharmaceutical formulation: Tablet Mode of Administration: Oral
Pharmaceutical formulation: Tablet Mode of Administration: Oral
Locations(12)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05975983