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

NCT03809052 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2021-03-17

Study results available
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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.

Conditions

  • Safety and Tolerability

Interventions

DRUG

GB1211

Hard capsules for oral use

DRUG

Placebo

Hard capsules for oral use

Sponsors & Collaborators

  • Galecto Biotech AB

    lead INDUSTRY

Principal Investigators

  • Dr Ashley Brooks, MBChB · Covance

  • Dr Bertil Lindmark MD PHD, Chief Medical Officer · Galecto Biotech AB

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-14
Primary Completion
2019-06-25
Completion
2019-06-25

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT03809052 on ClinicalTrials.gov