Overweight and Obesity
Conditions
Brief summary
This is a randomized, double-blind, placebo-controlled, dose-escalation phase I clinical study. A sequential design is used in this trial with a single dose escalation climb test, to investigate the safety, tolerability, and PK/PD characteristics of GZR18 injection in Chinese obese/overweight subjects.
Interventions
OTHERPlacebo
administered the same volume as GZR18
DRUGGZR18
5 mg-maximum tolerated dose (MTD), single dose
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 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects sign the informed consent form (ICF) voluntarily. * Chinese adult subjects, both male and female. * 18 to 65 years old (including both ends) at screening. * BMI≥26.0 kg/m2 at screening. * Stable weight before screening (i.e. self-reported weight change less than 5 kg within 8 weeks before screening). * Female subjects have negative serum Human Chorionic Gonadotropin (HCG) during screening and baseline periods. * Subjects have good daily habits and can maintain good communication with investigators and comply with various requirements of clinical trials.
Exclusion criteria
* Lactating women. * History of fainting with blood and needles. * Known or suspected allergy to study related products; or drug/food allergy history; or allergy-related diseases history. * Subjects who have participated in other clinical trials and given investigational drugs or medical device interventions within 90 days before screening. * History of drug abuse within 1 year before screening, or positive results in drug abuse screening (urine). * Smokers who smoke ≥ 5 cigarettes per day within the previous 3 months before screening or cannot refrain from smoking throughout the trial period. * Any vaccine has been used within 28 days before administration, as well as any vaccine that may be used throughout the trial period. * Other scenarios judged by the investigator to render the subjects unsuitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TEAE | 50 days | Incidence of Treatment Emergent Adverse Event(s) |
| Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab) | 50 days | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUClast | 50 days | area under the curve from 0 through the time of the last accurately measurable concentration |
| AUC0-inf | 50 days | area under the curve extrapolated to infinity |
| Tmax | 50 days | time to maximum plasma drug concentration |
| λz | 50 days | elimination rate constant |
| t1/2 | 50 days | half-life |
| Weight | 50 days | — |
| CL/F | 50 days | apparent clearance |
| Vz/F | 50 days | volume of distribution/F |
| AUC%extra | 50 days | percent of AUC0-inf extrapolated |
| Cmax | 50 days | Maximum plasma drug concentration |
| MRT | 50 days | mean residence time |
| tlag | 50 days | lag time |
| Body Mass Index (BMI) | 50 days | — |
Countries
China
Outcome results
None listed