T2D
Conditions
Brief summary
This study is a single-center, open-label, randomized, single-dose bioequivalence trial conducted in healthy adult participants.
Interventions
DRUGGZR4 injection A
GZR4 s.c., single-dose
DRUGGZR4 injection B
GZR4 s.c., single-dose
Sponsors
Gan & Lee Pharmaceuticals.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 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. 2\. Male, aged 18 to 50 years (inclusive) at the time of ICF signing. 3. Body weight ≥ 50 kg and body mass index (BMI) within the range of 18.5 to 24.0 kg/m² (inclusive) at screening. 4\. Male participants of childbearing potential have no plans for conception, voluntarily adopt effective contraceptive measures, and have no sperm donation plans from the date of ICF signing until 4 weeks after dosing.
Exclusion criteria
* 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. 2\. Findings from physical examination, vital signs, routine laboratory tests, 12-lead electrocardiogram (ECG), chest imaging and other assessments at screening are judged to be clinically significant by the investigator. 3\. Have special dietary requirements and are unable to comply with the standardized diet. 4\. Have a history of needle phobia or blood phobia, have difficulty in blood collection, or cannot tolerate venous puncture for blood sampling. 5\. The participant is an employee of the investigator or the study center, or a family member of an employee or the investigator; or the participant has other factors that, in the investigator's opinion, make him/her unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | Day1-Day29 | Peak concentration following single administration of GZR4 |
| AUC₀-t | Day1-Day29 | Area under the plasma concentration-time curve from time zero to the last quantifiable sampling time point t after single administration of GZR4 |
| AUC₀-∞ | Day1-Day29 | Area under the plasma concentration-time curve from time zero to infinity after single administration of GZR4 |
Secondary
| Measure | Time frame |
|---|---|
| Tmax | Day1-Day29 |
| t1/2 | Day1-Day29 |
| AUC_%Extrap | Day1-Day29 |
Countries
China
Contacts
CONTACTYunda Zhuge
CONTACTShiyun Lai
Outcome results
None listed