A Phase I Study of GZR18 Injection in Obese/Overweight Subjects
- Registration Number
- NCT06548945
- Lead Sponsor
- Gan and Lee Pharmaceuticals, USA
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description GZR18 GZR18 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method TEAE 50 days Incidence of Treatment Emergent Adverse Event(s)
Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab) 50 days
- Secondary Outcome Measures
Name Time Method 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
t1/2 50 days half-life
Body Mass Index (BMI) 50 days tlag 50 days lag time
Vz/F 50 days volume of distribution/F
AUC%extra 50 days percent of AUC0-inf extrapolated
MRT 50 days mean residence time
Weight 50 days Tmax 50 days time to maximum plasma drug concentration
Cmax 50 days Maximum plasma drug concentration
λz 50 days elimination rate constant
CL/F 50 days apparent clearance
Trial Locations
- Locations (1)
Gan & Lee Pharmaceuticals Co., Ltd
🇨🇳Beijing, China