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).
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
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
Parallel
INS018_055
DrugPharmaceutical formulation: Tablet Mode of Administration: Oral
Placebo
DrugPharmaceutical formulation: Tablet Mode of Administration: Oral
Percentage of subjects who have at least 1 treatment-emergent adverse event (TEAE)
Maximum plasma concentration (Cmax) of INS018_055 and its major metabolites (INS018_063 and INS018_095)
Time to reach maximum plasma concentration (Tmax) of INS018_055 and its major metabolites (INS018_063 and INS018_095)
Area under the plasma concentration-time curve from time zero to dosing interval τ (AUC0-τ) of INS018_055 and its major metabolites (INS018_063 and INS018_095)
Area under the plasma concentration-time curve from time zero to time with last measurable concentration t (AUC0-t) of INS018_055 and its major metabolites (INS018_063 and INS018_095)
Click on the lead sponsor to view all of their trials.
