Status:
COMPLETED
A Phase I Study of GZR18 Injection in Obese/Overweight Subjects
Lead Sponsor:
Gan and Lee Pharmaceuticals, USA
Conditions:
Overweight and Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06548945
Start Date
April 25 2023
End Date
August 14 2023
Last Update
August 14 2024
Active Locations (1)
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1
Gan & Lee Pharmaceuticals Co., Ltd
Beijing, China