A Randomized, Double-Blind, Placebo-Controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (PK/PD) of a Single Dose of GZR18 Injection in Obese/Overweight Subjects

Gan and Lee Pharmaceuticals, USA1 site in 1 country16 target enrollmentApril 25, 2023

ConditionsOverweight and Obesity

InterventionsGZR18 Placebo

Overview

Phase: Phase 1
Intervention: GZR18
Conditions: Overweight and Obesity
Sponsor: Gan and Lee Pharmaceuticals, USA
Enrollment: 16
Locations: 1
Primary Endpoint: TEAE
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 25, 2023

End Date

August 14, 2023

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Gan and Lee Pharmaceuticals, USA

Responsible Party

Sponsor

Eligibility Criteria

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.