NCT03809052

A First in Human Study to Evaluate the Safety, Tolerability and PK of GB1211 in Healthy Subjects

GB1211 - A Randomised, Double-Blind, Placebo-Controlled, First-In-Human, Study of Orally Administered GB1211 to Evaluate the Safety, Tolerability, and PK of Single Ascending Doses (SAD) and Multiple Ascending Doses (MAD) in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Galecto Biotech AB · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This was a Phase 1, randomized, double-blind, placebo-controlled, first-in-human study in which the safety, tolerability, and pharmacokinetics of orally administered GB1211 will be evaluated in healthy adult subjects and adult subjects with indication of suspected Nonalcoholic steatohepatitis (NASH) and liver fibrosis.

Detailed description

The study consisted of 2 parts: a SAD phase (Part A) which enrolled a total of 5 cohorts of healthy subjects and a MAD phase (Part B) which enrolled 2 cohorts of healthy subjects. Two additional cohorts A6 and A7, were added following dose escalation analysis. The planned optional Part C was to include a multiple-dose cohort of 25 subjects with suspected NASH and liver fibrosis (Cohort C1). However, Part C of the study was not performed as per Sponsor's decision.

Conditions

• Safety and Tolerability

Interventions

Type	Name	Description
DRUG	GB1211	Hard capsules for oral use
DRUG	Placebo	Hard capsules for oral use

Timeline

• Start date: 2019-01-14
• Primary completion: 2019-06-25
• Completion: 2019-06-25
• First posted: 2019-01-18
• Last updated: 2021-03-17
• Results posted: 2021-02-23

Locations

1 site across 1 country: United Kingdom