About this trial
This study is a single-center, open-label, randomized, single-dose bioequivalence trial conducted in healthy adult participants.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
1. Voluntarily sign the Informed Consent Form (ICF), be willing to accept subcutaneous injection, fully understand the study content, procedures and potential adverse reactions, and be able to comply with the contraindications and restrictions specified in this protocol.
Disqualifiers
1. Have an allergic constitution, or a history of allergic diseases such as bronchial asthma and eczema (except for mild seasonal allergy); or have a history of severe food allergy (e.g., laryngeal edema, shock); or known allergy, hypersensitivity or intolerance to the investigational medicinal product (IMP) or similar products or their excipients; or have a clinically significant history of drug allergy or atopic allergic diseases.
Trial design
Parallel
Treatments tested in this trial
GZR4 injection A
DrugGZR4 s.c., single-dose
GZR4 injection B
DrugGZR4 s.c., single-dose
Treatment groups
Trial outcomes
Primary outcomes
Cmax
Peak concentration following single administration of GZR4
AUC₀-t
Area under the plasma concentration-time curve from time zero to the last quantifiable sampling time point t after single administration of GZR4
AUC₀-∞
Area under the plasma concentration-time curve from time zero to infinity after single administration of GZR4
Secondary outcomes
Tmax
t1/2
AUC_%Extrap
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: