At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 78 enrolled
Drug / intervention
GB1211 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating GB1211 and Placebo for Safety and Tolerability. Completed, enrolled 78 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSafety and Tolerability
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
Enrollment StartJan 2019
First PostedJan 2019
Primary CompletionJun 2019
TodayJul 2026
First PostedJan 18, 2019
Enrollment StartJan 14, 2019
Primary CompletionJun 25, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 7.5 years ago
Interventions
GB1211drug
Hard capsules for oral use
Placebodrug
Hard capsules for oral use