This will be a Phase I, double-blind, randomized, placebo-controlled study conducted in 2 parts, single and multiple inhaled dose, at multiple sites. The purpose of this study is to find out about the safety and tolerability of TRK-250 after single and multiple inhaled doses in subjects with idiopathic pulmonary fibrosis (IPF). TRK-250 is an experimental drug which is not approved by the United States Food and Drug Administration (FDA) for the treatment of idiopathic pulmonary fibrosis. This study will be the first time that TRK-250 is administered to humans. This study will be conducted in 2 parts, single inhaled dose (Part A) and multiple
inhaled doses (Part B). Part A of this study will have 6 study visits over a period of up to no more than 9 weeks. Part B of this study will have 7 study visits over a period of 10 weeks.
The purpose of this research study is to evaluate the long-term safety and tolerability of the study drug called nintedanib in subjects with Systemic Sclerosis and associated Interstitial Lung Disease. Patients who have completed (did not prematurely discontinue trial medication) SENSCISTM (1199.214) can participate in this study. Unlike 1199.214, patients will will know the dose of the study drug. Treatment duration for each patient will be variable. Treatment will be stopped if a reason for withdrawal is met The patient will be in this study about 3 years and have about 26 visits to the study center. These visits include physical exams, blood and urine samples, urine pregnancy testing, collection of unused study drug, and receiving the study drug supply at the reduced dose.
This is a research study to find out the safety and efficacy of a drug called BG00011 and to find the best dosage. The study drug will be given by an injection under the skin, also called subcutaneously (SC), once a week during the treatment period. Study treatment will be given to you and you will be trained on how to inject yourself with the study drug/placebo in a prefilled syringe. You can ask for re-training at any time during the study. You will be in the study for up to 65 weeks (including a Screening visit, a Study Treatment Period of 52 weeks, and a Safety Follow-Up visit). This study is a randomized, double blind, placebo controlled study.
The purpose of this study is to evaluate the safety of the study drug ND-L02-s0201 when administered at two dose levels compared with placebo (A placebo looks like the study drug, but the injection does not contain the active ingredient in ND-L02-s0201) to help with IPF. ND-L02-s0201 is being developed to treat fibrosis (scarring) of the lungs. ND-L02-s0201 is made up of tiny particles of fat that contain modified vitamin A and help carry the drug through the body and to reach special cells in the lung. It is hoped that the study drug will slow the progression of fibrosis in your lungs. You will be involved in the study for up to 40 weeks (about 10 months).