A Randomized, Double-blind, Placebo-controlled, Parallel, Multicenter, Exploratory Phase IIa Clinical Trial to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Properties of SB17170 in Idiopathic Pulmonary Fibrosis (IPF) Patients.
This clinical trial is a 2:2:1 randomized, double-blind, placebo-controlled, parallel group, exploratory phase II trial. The main objective of this trial is to compare and evaluate change in FVC compared to placebo by administering SB17170 to moderate to severe patients with IPF. This clinical trial treatment involves administering SB17170 or placebo for 12 weeks.
• Adult male/female 40 years or older at the time of obtaining informed consent
• Patients diagnosed with idiopathic pulmonary fibrosis who meet the following criteria:
‣ Patients with idiopathic pulmonary fibrosis who are confirmed by chest High-Resolution Computed Tomography (HRCT) scan
⁃ Patients with Usual Interstitial Pneumonia (UIP) or probable UIP HRCT pattern consistent with a diagnosis of idiopathic pulmonary fibrosis confirmed through central reading of chest HRCT before the baseline visit
• Patients with a history of idiopathic pulmonary fibrosis treatment who meet the defined criteria
• Patients with Forced Vital Capacity (FVC) ≥ 45% of the normal predicted value at the screening visit
• Patients meeting pulmonary function test criteria at the screening visit
• Patients who have received the explanation of this clinical trial and voluntarily agreed and signed the informed consent form