Bioequivalence Study of GZR4 Injection With Different Manufacturing Processes in Healthy Adult Participants

ConditionT2D
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-50
SponsorGan & Lee Pharmaceuticals.

About this trial

This study is a single-center, open-label, randomized, single-dose bioequivalence trial conducted in healthy adult participants.

Eligibility criteria

Qualifiers

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

Treatments tested in this trial

  • GZR4 injection A
  • GZR4 injection B

Treatment groups

64 Participants
are divided into 2 treatment groups

Sponsors and collaborators