U.S., Jan. 22 -- ClinicalTrials.gov registry received information related to the study (NCT07355738) titled 'Bioequivalence Study of GZR18 Injection Before and After CMC Change' on Jan. 05.
Brief Summary: This is an open-label, randomized, single-dose, parallel comparison bioequivalence study conducted in healthy adult male subjects.
The study is divided into 3 parts, each of which evaluates the bioequivalence of GZR18 Injection for one strength before and after CMC changes.
Subjects eligible for each part of the screening will be randomized into Group A or Group B in a 1:1 ratio. Each subject will receive a single dose of GZR18 Injection, followed by PK blood sampling and safety follow-up for 35 days. Subjects will be admitted to the ho...