Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single-dose GZR4

A Single-center, Single-administration, Randomized, Placebo-controlled, Dose-escalation Trial Evaluated the Safety, Tolerability, PK, and PD Parameters of GZR4 in Healthy Male Adult Subjects

This trial is conducted in China. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single-dose GZR4.

Inclusion Criteria:

• 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 Criteria:

• 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