| Trial ID: | L3143 |
| Source ID: | NCT05328726
|
| Associated Drug: |
Gzr-18
|
| Title: |
Single, Ascending Dose, First Time in Human Study for GZR18 in Healthy Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: GZR-18|OTHER: Placebo
|
| Outcome Measures: |
Primary: Dose limiting toxicity, The primary outcome for this study is Dose Limiting Toxicity, which is the composite of any SAE, any pancreatitis(as measured by amylase) or renal dysfunction (as measured by serum creatinine), Up to 31 days | Secondary: Maximum Plasma Concentration, Cmax, Up to 720 hours|Glycosylated Hemoglobin, HbA1c, Up to 720 hours
|
| Sponsor/Collaborators: |
Sponsor: Gan and Lee Pharmaceuticals, USA
|
| Gender: |
MALE
|
| Age: |
ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-03-08
|
| Completion Date: |
2023-03-09
|
| Results First Posted: |
|
| Last Update Posted: |
2023-03-23
|
| Locations: |
Celerion, Lincoln, Nebraska, 68502, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05328726
|
