Nitto Denko Study
Condition: Idiopathic pulmonary fibrosis
Full Study Name
A Phase II, Randomized Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability Biological Activity and PK of ND-L02-S0201 in Subjects With Idiopathic Pulmonary Fibrosis (IPF) (IRB no. 53899)
This study focuses on individuals who have idiopathic pulmonary fibrosis (IPF) and are between 40 and 80 years old. The purpose of the study is to evaluate the safety of an experimental medication called ND‑L02‑s0201 when administered at two dose levels compared with placebo (inactive substance).
ND-L02-s0201 is made up of tiny particles of fat that also contain a small amount of RNA (ribonucleic acid) that is the active drug. The RNA in ND-L02-s0201 is designed to block the lungs from making a protein called "heat shock protein 47" (HSP47) for a limited period of time. It is thought that blocking the lungs from making HSP47 will help treat IPF because one of the roles of HSP47 is to help make collagen, which is involved in fibrosis (scarring).
Participation in the study will be approximately 40 weeks, including a screening and baseline period of up to 6 weeks, a treatment period of 24 weeks and a follow-up period of 10 weeks. Participants will attend 16-17 on-site visits at Cedars-Sinai and will receive an IV study drug infusion every 2 weeks at Cedars-Sinai during the treatment period.