Status:
COMPLETED
A Phase I Study of GZR18 Injection in Healthy Subjects
Lead Sponsor:
Gan and Lee Pharmaceuticals, USA
Conditions:
Type 2 Diabetes
Overweight and Obesity
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 we...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2022
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT06548997
Start Date
December 2 2021
End Date
October 20 2022
Last Update
August 14 2024
Active Locations (1)
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1
Gan & Lee Pharmaceuticals Co., Ltd
Beijing, China