Safety and Tolerability Study in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Status:
Active, not recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
This is a randomized, placebo-controlled, double-blind, 6-month study followed by a 6 month
open-label extension phase to evaluate the efficacy, safety, and tolerability of MN-001 in
moderate to severe IPF patients. MN-001 750 mg or matching placebo will be orally
administered twice daily over a 26 week period in subjects with a confirmed diagnosis of IPF
per the ATS )American Thoracic Society) 2011 Guidelines. Approximately 15 subjects are
planned to be enrolled. This study will consist of two treatment arms, MN-001 and matching
placebo. Randomization will occur in a 2:1 ratio (MN-001: placebo). Eligible subjects will
consist of males and females ranging in age from 21 to 80 years old, inclusive.
The study will consist of a Screening Phase (up to 3 months prior to Day1) followed by a 26
week double-blind Treatment Phase, a 26 week Open-Label Extension (OLE) phase and a Follow-up
Visit (within 4 weeks after the last dose).