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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • GZR4 injection A

    Drug

    GZR4 s.c., single-dose

  • GZR4 injection B

    Drug

    GZR4 s.c., single-dose

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: GZR4 injection AExperimental treatment 1 intervention
Group B: GZR4 injection BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cmax

Peak concentration following single administration of GZR4

Time frame
Day1-Day29
2

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

Time frame
Day1-Day29
3

AUC₀-∞

Area under the plasma concentration-time curve from time zero to infinity after single administration of GZR4

Time frame
Day1-Day29

Secondary outcomes

1

Tmax

Time frame
Day1-Day29
2

t1/2

Time frame
Day1-Day29
3

AUC_%Extrap

Time frame
Day1-Day29

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: