NCT02257177

A Placebo-controlled RCT in HV's Investigating the Safety, Tolerability and PK (Pharmacokinetic) of TD139, a Galectin-3 Inhibitor, Followed by an Expansion Cohort Treating Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Completed Phase 1/Phase 2 Results posted Last updated 3 November 2023

What this trial tests

Phase 1/Phase 2 trial testing Inhaled TD139 in Idiopathic Pulmonary Fibrosis in 60 participants. Completed in 1 December 2016.

Timeline

1 September 2014

Primary endpoint
1 December 2016

1 December 2016

Quick facts

Lead sponsor	Galecto Biotech AB
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	1 September 2014
Primary completion	1 December 2016
Estimated completion	1 December 2016
Sites	5 locations across United Kingdom

Drugs / interventions tested

• Inhaled TD139 — full drug profile →
• Placebo

Conditions studied

• Idiopathic Pulmonary Fibrosis — all drugs for Idiopathic Pulmonary Fibrosis →

Sponsor

Galecto Biotech AB — full company profile →

Who can join

Adults 18 to 85, any sex, with Idiopathic Pulmonary Fibrosis. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Participants With Adverse Events
  Time frame: 0 - 30 days
  Number of participants reporting Adverse Events from the date of first dose, until 30 days post first dose.

Sponsor's own description

This study will be divided into 2 parts. Part 1 is a randomized, double-blind, single centre, placebo-controlled, single ascending dose (SAD) phase I study designed to assess the safety, tolerability, PK and PD (Pharmacodynamic) of TD139 in up to 36 healthy male subjects. Part 2 will be a randomized, 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Idiopathic Pulmonary Fibrosis (IPF): An Overview.
   Barratt SL, Creamer A, Hayton C, Chaudhuri N. · · 2018 · cited 258× · PMID 30082599 · DOI 10.3390/jcm7080201
2. Galectin-3: One Molecule for an Alphabet of Diseases, from A to Z.
   Sciacchitano S, Lavra L, Morgante A, Ulivieri A, et al · · 2018 · cited 258× · PMID 29373564 · DOI 10.3390/ijms19020379
3. Idiopathic Pulmonary Fibrosis and Lung Cancer: Mechanisms and Molecular Targets.
   Ballester B, Milara J, Cortijo J. · · 2019 · cited 243× · PMID 30704051 · DOI 10.3390/ijms20030593
4. Idiopathic pulmonary fibrosis: Current and future treatment.
   Glass DS, Grossfeld D, Renna HA, Agarwala P, et al · · 2022 · cited 206× · PMID 35001525 · DOI 10.1111/crj.13466
5. Target inhibition of galectin-3 by inhaled TD139 in patients with idiopathic pulmonary fibrosis.
   Hirani N, MacKinnon AC, Nicol L, Ford P, et al · · 2021 · cited 173× · PMID 33214209 · DOI 10.1183/13993003.02559-2020
6. Targeting cardiac fibrosis in heart failure with preserved ejection fraction: mirage or miracle?
   Sweeney M, Corden B, Cook SA. · · 2020 · cited 142× · PMID 32955172 · DOI 10.15252/emmm.201910865
7. Current and Future Treatment Landscape for Idiopathic Pulmonary Fibrosis.
   Bonella F, Spagnolo P, Ryerson C. · · 2023 · cited 100× · PMID 37882943 · DOI 10.1007/s40265-023-01950-0
8. Emerging therapies for idiopathic pulmonary fibrosis, a progressive age-related disease.
   Mora AL, Rojas M, Pardo A, Selman M. · · 2017 · cited 99× · PMID 29081515 · DOI 10.1038/nrd.2017.225