This trial is a randomized, double-blind, three-period crossover Phase I Clinical Study conducted in Chinese adult overweight subjects to evaluate the safety, tolerability, PK and PD profiles of a single dose of GZR102 injection versus GZR4 injection and GZR18 injection given separately.
Subjects undergo a screening phase of up to 3 weeks (D-21 to D-3). Eligible subjects are randomized in a 1:1:1:1:1:1 ratio into six dosing sequences, receiving single doses of GZR102 injection, GZR4 injection, and GZR18 injection across 3 cycles. A washout period of at least 1 week separates each cycle.
1. Subjects sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and be able to follow the contraindications and restrictions specified in this protocol.
1. History of drug abuse prior to screening; or positive results for drug abuse at screening.
Crossover
GZR102 injection
DrugParticipants will get a single dose of GZR102 injection （fixed-ratio combination of GZR4 and GZR18）.
GZR4 injection
DrugParticipants will get a single dose of GZR4 injection
GZR18 injection
DrugParticipants will get a single dose of GZR18 injection
AUC0-t
Area under the plasma concentration-time curve at 0 h to last observation time-point after a single dose.
AUC0-inf
Area under the plasma concentration-time curve at 0 h to infinity after a single dose.
TEAEs
Treatment-emergent adverse events in terms of number of subject
Hypoglycemia
Number of subjects, number of events and incidence of treatment-emergent hypoglycemia.
Immunogenicity
Including anti-drug antibody (ADA) and neutralizing antibody (NAb).
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