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A Study to Test the Efficacy and Safety of Inhaled GB0139 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

NCT03832946 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2024-05-22

Study results available
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Summary

This is a randomized, double-blind, placebo-controlled phase 2b trial in subjects with IPF (idiopathic pulmonary fibrosis) investigating the efficacy and safety of GB0139.

Conditions

  • Idiopathic Pulmonary Fibrosis (IPF)

Interventions

DRUG

GB0139

GB0139 is a galectin-3 inhibitor designed to modulate the fibrogenic response to tissue injury. It is administered as inhalation once a day.

DRUG

Placebo

Placebo is administered as inhalation once a day

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • bioRASI, LLC

    collaborator INDUSTRY

  • Galecto Biotech AB

    lead INDUSTRY

Principal Investigators

  • Toby Maher, MD, PhD · Keck Medicine of USC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-19
Primary Completion
2023-05-17
Completion
2023-05-17
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • Georgia
  • Germany
  • Ireland
  • Israel
  • Italy
  • Poland
  • Russia
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03832946 on ClinicalTrials.gov