| Trial ID: | L0778 |
| Source ID: | NCT03809052
|
| Associated Drug: |
GB1211
|
| 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
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Safety and Tolerability
|
| Interventions: |
Drug: GB1211;Drug: Placebo
|
| Outcome Measures: |
Change versus placebo in number of subjects with adverse events;Change versus placebo in number of subjects with abnormal laboratory parameters;Change versus placebo in number of subjects with abnormal vital signs;Change versus placebo in number of subjects with abnormal electrocardiogramEvaluation of Pharmacokinetics of GB1211 in plasma;Evaluation of Pharmacokinetics of GB1211 in plasma;Evaluation of Pharmacokinetics of GB1211 in plasma;Evaluation of Pharmacokinetics of GB1211 in plasma;Evaluation of Pharmacokinetics of GB1211 in plasma;Evaluation of Pharmacokinetics of GB1211 in plasma;Evaluation of Pharmacokinetics of GB1211 in urine;Evaluation of Pharmacokinetics of GB1211 in urine;Evaluation of Pharmacokinetics of GB1211 in urine;Evaluation of Pharmacokinetics of GB1211 in plasma;Evaluation of Pharmacokinetics of GB1211 in plasma;Evaluation of Pharmacokinetics of GB1211 in plasma
|
| Sponsor/Collaborators: |
Galecto Biotech AB
|
| Gender: |
All
|
| Age: |
18 Years60 Years
|
| Phases: |
Phase 1
|
| Enrollment: |
87
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Other. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
| Start Date: |
07/12/2018
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
12 December 2020
|
| Locations: |
United Kingdom
|
| URL: |
https://clinicaltrials.gov/show/NCT03809052
|
