This study will assess the safety and tolerability of inhaled LTI-03 in treatment naïve participants with newly diagnosed IPF.
This is a randomized, double-blind, placebo controlled, multi-center, dose escalation, safety and tolerability study of LTI-03 or placebo administered by inhalation in participants recently diagnosed with idiopathic pulmonary fibrosis that have not received prior treatment with anti-fibrotic agents. The study will contain 2 dose cohorts which will run sequentially. Eligible participants will be randomized in a 3:1 ratio to either LTI-03 or placebo. Safety data will be reviewed on an ongoing basis. Enrollment in the second cohort will not begin until the Cohort 1 safety data has been reviewed. The Treatment Period will be 14 days, with subjects self-administering study drug using a provided commercially available dry-powder inhaler.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
24
University of Alabama
Birmingham, Alabama, United States
University of Southern California
Los Angeles, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Agaplesion Evangelisches Krankenhaus Mittelhessen
Giessen, Germany
Incidence of Treatment-emergent Adverse Events (TEAEs)
Incidence of TEAEs by dose
Time frame: 21 days (dosing x 14 days; follow up x 7 days)
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University of Edinburgh
Edinburgh, United Kingdom
Royal Brompton Hospital
London, United Kingdom
Royal Victoria Infirmary
Newcastle, United Kingdom