A Study to Investigate Single and Multiple Doses of TD139
Research type
Research Study
Full title
A randomised, double-blind, multi centre, placebo-controlled dose escalation study in healthy subjects investigating the safety, tolerability and pharmacokinetic properties of TD139, a galectin-3 inhibitor, followed by an expansion cohort treating subjects with idiopathic pulmonary fibrosis (IPF)
IRAS ID
159642
Contact name
Toby Maher
Contact email
Sponsor organisation
Galecto Biotech
Eudract number
2014-001187-35
Research summary
This study is looking at a drug called TD139 which is a novel inhaled drug designed as a therapy for Idiopathic Pulmonary Fibrosis (IPF). TD139 is an inhaled compound formulated for dry powder inhalation and is a galectin-3 inhibitor. Galectin-3 is a member of the lectin family of carbohydrate-binding proteins and it is implicated in a number of cellular processes, including cell adhesion, cell activation, chemo-attraction, cell growth, differentiation and apoptosis.
This study will be divided into 2 parts. Part 1 is a randomised, double-blind, single centre, placebo-controlled, single ascending dose (SAD) phase I study designed to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of TD139 in up to 36 healthy male subjects. Part 2 will be a randomised, double-blind, multi-centre, placebo-controlled, multiple dose expansion cohort, designed to assess the safety, tolerability, PK and PD of TD139 in up to 24 male subjects and female subjects of non child-bearing potential with IPF.
Part 1 of the study will take place in healthy male volunteers and will consist of up to 6 cohorts of 6 subjects. Within each cohort, 4 subjects will receive a single dose of TD139 and 2 subjects will receive a single dose of placebo. The lowest dose of TD139 will be evaluated first (0.15 mg).
Part 2 of the study will take place in male subjects and female subjects of non child-bearing potential with IPF. This part of the study will consist of 1 cohort of up to 24 IPF subjects, who will receive a single dose of TD139 or placebo via DPI once daily for 14 days (16 subjects will receive TD139 and 8 subjects will receive placebo).
REC name
London - Brent Research Ethics Committee
REC reference
14/LO/1357
Date of REC Opinion
8 Aug 2014
REC opinion
Favourable Opinion