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

Gan and Lee Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Diabetes

Treatments

Drug: GZR4

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06548815

GL-GZR-CH1004

Details and patient eligibility

About

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

Enrollment

43 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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