Overweight and Obesity, Type 2 Diabetes
Conditions
Brief summary
This trial is conducted in China. The aim of the trial is to evaluate the safety and tolerability of GZR18 injection in healthy subjects following single dose and once-weekly dose for 2 consecutive weeks until reaching the target dose.
Interventions
DRUGGZR18
5 μg/kg-maximum tolerated dose (MTD), single dose or two doses
OTHERPlacebo
administered the same volume as GZR18
Sponsors
Gan and Lee Pharmaceuticals, USA
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 1\. Subjects sign informed consent voluntarily. * 2\. Chinese adult subjects, male or female. * 3\. Age 18-55 at screening (both included). * 4\. At screening and baseline, 19.0 kg/m2 ≤ BMI ≤ 26.0 kg/m2 (male ≥55.0 kg, female ≥45.0 kg). * 5\. Female subjects were human chorionic gonadotophin (HCG) negative at screening and baseline.
Exclusion criteria
* 1\. History of dizziness with blood and needles. * 2\. Known or suspected allergy to study related products; or a history of drug and food allergies; or a history of allergy-related diseases. * 3\. Participants who participated in other clinical trials and were given the investigational drug or medical device intervention within 90 days prior to screening. * 4\. Blood donation, surgery, or trauma with significant blood loss (more than or equal to 400 mL, except for menstrual blood loss in women) within 12 weeks prior to screening. * 5\. Any clinically significant medical history judged by the investigator, including but not limited to: lung, gastrointestinal, liver, nervous system, kidney, genitourinary and endocrine, skin, or blood disorders, especially a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 , and a history of pancreatitis (acute or chronic). * 6\. At screening or baseline, physical examination showed clinically significant abnormalities judged by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TEAE | after 28/35 days of treatment | Incidence of treatment-emergent adverse events (TEAE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUClast | 28/35 days | the area under the concentration-time curve from 0 to the last time that the concentration can be accurately measured |
| AUC0-inf | 28/35 days | the area under the concentration-time curve from 0 to infinity |
| Tmax | 28/35 days | the peak time |
| λz | 28/35 days | the elimination rate constant |
| t1/2 | 28/35 days | the half-life |
| tlag | 28/35 days | retention time |
| CL/F | 28/35 days | apparent clearance rate |
| Cmax | 28/35 days | The peak concentration after reaching the target dose |
| AUC%extra | 28/35 days | extrapolation percentage of AUC0-in |
| MRT | 28/35 days | average retention time |
| AUCglucose0-14h | 28/35 days | area under the concentration-time curve of fasting blood glucose from 0 to 14 hours after each administration |
| AUCc-peptide0-14h | 28/35 days | area under the concentration-time curve of fasting C-peptide from 0 to 14 hours after each administration |
| AUCinsulin0-14h | 28/35 days | area under the concentration-time curve of fasting insulin from 0 to 14 hours after each administration |
| body weight | 28/35 days | — |
| body mass index (BMI） | 28/35 days | — |
| Vz/F | 28/35 days | apparent volume of distribution |
Countries
China
Outcome results
None listed