Diabetes Mellitus, Type 2
Conditions
Brief summary
The aim of the trial is to investigate the the bioavailability, pharmacokinetics, pharmacodynamics, safety and tolerance of single and multiple doses of GZR18 tablet in healthy subjects.
Interventions
DRUGGZR18
Oral administered the GZR18 tablet
Sponsors
Gan and Lee Pharmaceuticals, USA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects sign informed consent voluntarily. 2. Age 18-55 at screening (both included)，male or female（male only for part A）. 3. At screening, 20.0 kg/m2 ≤ BMI ≤ 24.9 kg/m2, body weight≥54.0 kg. 4. Female subjects were HCG negative at screening and baseline
Exclusion criteria
1. Female subjects who are pregnant or lactating at screening. 2. History of drug abuse within 1 year prior to screening, with a positive drug abuse screening result at screening or before dosing. 3. Abnormal fasting blood glucose at screening, or impaired glucose tolerance, or history of hypoglycemia within 3 months prior to screening. 4. History of the following diseases with a definite diagnosis within 6 months prior to screening: cardiovascular disease, hematologic disease, respiratory disease, abnormal liver function due to acute and chronic hepatitis or other reasons, abnormal renal function, endocrine and metabolic system disease, neuropsychiatric disease, skin and subcutaneous tissue disease, musculoskeletal system disease, immune system disease, or the presence of other diseases that may interfere with the interpretation of study results. 5. Those who have any food allergies or special dietary requirements and cannot follow a uniform diet.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AE and SAE | 22 days and 35 days | Incidence of Adverse Events and Severe Adverse Events |
| Relative bioavailability of GZR18 tablet | 22 days and 35 days | Fr =AUC0-t(GZR18 tablets)/AUC0-t(GZR18 injection)×100% |
| ADA and NAb | 22 days and 35 days | Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 22 days and 35 days | Maximum plasma drug concentration |
| AUC0-t | 22 days and 35 days | Area under the curve from 0 through the time of the last accurately measurable concentration |
| AUC0-24h | 22 days and 35 days | Area under the curve from 0 h to 24 hours |
Countries
China
Outcome results
None listed