| Trial ID: | L7289 |
| Source ID: | NCT06554054
|
| Associated Drug: |
Gzr18
|
| Title: |
A Study of GZR18 Tablet in Chinese Healthy Subjects
|
| Acronym: |
|
| Status: |
ACTIVE_NOT_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: GZR18
|
| Outcome Measures: |
Primary: AE and SAE, Incidence of Adverse Events and Severe Adverse Events, 22 days and 35 days|Relative bioavailability of GZR18 tablet, Fr =AUC0-t(GZR18 tablets)/AUC0-t(GZR18 injection)×100%, 22 days and 35 days|ADA and NAb, Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab), 22 days and 35 days | Secondary: Cmax, Maximum plasma drug concentration, 22 days and 35 days|AUC0-t, Area under the curve from 0 through the time of the last accurately measurable concentration, 22 days and 35 days|AUC0-24h, Area under the curve from 0 h to 24 hours, 22 days and 35 days
|
| Sponsor/Collaborators: |
Sponsor: Gan and Lee Pharmaceuticals, USA
|
| Gender: |
ALL
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
92
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2024-04-01
|
| Completion Date: |
2024-12-09
|
| Results First Posted: |
|
| Last Update Posted: |
2024-08-14
|
| Locations: |
Study Site 01, Beijing, China
|
| URL: |
https://clinicaltrials.gov/show/NCT06554054
|
