Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single-dose GZR4
Lead Sponsor:
Gan and Lee Pharmaceuticals, USA
Conditions:
Diabetes
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
This trial is conducted in China. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single-dose GZR4.
Eligibility Criteria
Inclusion
- Chinese healthy male adult subjects aged 18-45 years old
- Body mass index \[BMI between 19.0-24.0 kg/m2
- Hemoglobin A1c (HbA1c)≤6%
Exclusion
- Abnormalities that were assessed by the investigators to be clinically significant at screening included vital signs, physical examination, laboratory testing, anteroposterior and lateral chest radiography, and 12-lead ECG
- Known severe allergies (e.g., allergy to more than 3 allergens, allergic asthma affecting the lower respiratory tract, allergy requiring glucocorticoid treatment) or known allergic history to the ingredients of the investigational drug used in this study
- Participants had donated blood ≥ 200 mL within 6 months before screening, or had donated blood components, or had a total blood loss of ≥ 200 mL due to any reason, or history of blood transfusion or use of blood products
- Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or treponema pallidum antibody positive
- Participated in other clinical trials and used investigational drugs or medical devices within 3 months before screening
Key Trial Info
Start Date :
August 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 24 2023
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT06548815
Start Date
August 29 2022
End Date
March 24 2023
Last Update
August 12 2024
Active Locations (1)
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1
Gan & Lee Pharmaceuticals Co., Ltd
Beijing, Beijing Municipality, China, 100000