TRK-250 ? A Phase I, Double-Blind, Placebo-Controlled, Single and Multiple Inhaled Dose, Safety, Tolerability, and Pharmacokinetic Study of TRK-250 in Subjects with Idiopathic Pulmonary Fibrosis Save

Date Added
March 26th, 2019
PRO Number
Pro00086393
Researcher
John Huggins

List of Studies


Profiles_link
Keywords
Lung, Pulmonary
Summary

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.

Institution
MUSC
Recruitment Contact
Abbi Reed
(843) 792-1820
reedab@musc.edu

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of BG00011 in Patients With Idiopathic Pulmonary Fibrosis Save

Date Added
August 28th, 2018
PRO Number
Pro00076525
Researcher
John Huggins

List of Studies


Profiles_link
Keywords
Drug Studies, Lung, Pulmonary
Summary

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.

Institution
MUSC
Recruitment Contact
Allison Patterson
(843) 792-5168
patteallmusc.edu

A PHASE 2, 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) Save

Date Added
August 14th, 2018
PRO Number
Pro00077835
Researcher
John Huggins

List of Studies


Profiles_link
Keywords
Lung, Pulmonary
Summary

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).

Institution
MUSC
Recruitment Contact
Daniel Larimore
(843) 792-6890
larimord@musc.edu

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