First in human study of GB1211
Research type
Research Study
Full title
GB1211 - A Randomised, Double-Blind, Placebo Controlled, First In Human, Study of Orally Administered GB1211 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (SAD) and Multiple Ascending Doses (MAD) in Healthy Subjects and in Subjects with Suspected Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis
IRAS ID
253682
Contact name
Ashley Brooks
Contact email
Sponsor organisation
Galecto Biotech
Eudract number
2018-003914-41
Duration of Study in the UK
0 years, 5 months, 24 days
Research summary
GB1211 (study drug) is being tested as potential treatment for fibrotic (scarring) diseases that may affect the liver, kidneys and heart. It acts by inhibiting Galectin-3, a protein known to play a key role in fibrosis and inflammation.
This study is a Phase 1 study and will take place in healthy subjects (Part A and B at a single clinical research unit) and adults with suspected Non-Alcoholic Steatohepatitis (NASH) and Liver Fibrosis. This will be the first time that GB1211 has been administered in humans.
Part A will be a single ascending dose study to examine 5 dose levels, each with cohorts of 8 subjects. One cohort will also explore the effect of food on the absorption of GB1211, these subjects will receive the study drug on 2 occasions in both the fed and fasted state. Part B will comprise 2 groups of 11 subjects and both Part A and B will be Multiple Ascending Dose studies.
For all Cohorts in Part A, sentinel dosing will be employed so that 2 subjects (1 active and 1 placebo) will be dosed 24 hours before the remaining 6 subjects, following review of data by the Investigator. The same technique will be applied to Part B if data from Part shows this is required. The dose level for each Cohort in Part A & B will be decided following thorough review of the safety data from the previous Cohort.
The planned study duration for Cohorts in Part A will be approximately 5 weeks, and up to 7 weeks for the group investigating the food effect; up to 7 weeks for Part B.
REC name
London - Brent Research Ethics Committee
REC reference
18/LO/1734
Date of REC Opinion
22 Nov 2018
REC opinion
Further Information Favourable Opinion