Study of GZR4 Injection Given Under the Skin at Abdomen, Upper Arm, and Thigh in Healthy Men Aged 18 to 55

What this Trial Is About

Researchers are evaluating the pharmacokinetics PK, pharmacodynamics PD, and safety of GZR4 Injection in healthy adult male volunteers aged 18 to 55 years. The study is a randomized, single-center, open, three-period crossover trial conducted in China, designed to compare the effects of a single dose of GZR4 when injected into different body sites. This phase 1 trial aims to understand how the drug behaves and acts in the body depending on the injection region. Participants will receive a single subcutaneous injection of GZR4 at one of three sites the abdomen, the deltoid region of the upper arm, or the thigh. Each participant will undergo all three injection site treatments in a crossover manner, allowing direct comparison of the drugs absorption and activity from these locations. The dosing schedule includes one injection per study period, with careful monitoring following each administration. During the study, participants will be closely observed with physical exams, vital signs, laboratory tests, imaging, and electrocardiograms to track safety and drug effects. Researchers will measure key outcomes such as drug exposure over time AUC0-672h, maximum concentration Cmax, and other pharmacodynamic markers. The total participation duration covers the study treatments and follow-up assessments extending up to 672 hours after each dose to ensure comprehensive data collection and safety monitoring.

A Study of GZR4 Injection at Different Injection Sites