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This study is a randomized, open-label, single-dose, parallel-controlled biosimilar comparison study comparing the pharmacokinetics, safety and immunogenicity of the investigational drug and the active comparator in healthy adult subjects. Eligible healthy participants will be screened and randomly assigned to the experimental group and the active comparator group at a ratio of 1:1 , semaglutide injection or Ozempic® injection 0.25mg abdominal subcutaneous injection will be given according to their groups. Follow-up for 5 weeks after administrtion.
Studies included a screening period (up to 2 weeks), baseline, administration (single dose), and a follow-up period (5 weeks). The duration of the study will be approximately 7 weeks for a participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Experimental group: Semaglutide injection, specifications: 1.34 mg/mL, 1.5 mL (pre-filled injection pen), 0.25 mg , subcutaneous abdominal injection. |
|
| Active Comparator | Active Comparator | Control group: Ozempic ® injection, 1.34 mg/mL, 1.5 mL (pre-filled injection pen), 0.25 mg , subcutaneous injection into the abdomen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozempic® | Drug | Participants will be given Ozempic ® injection 0.25mg abdominal subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-inf | Area Under the Concentration-time curve from time zero to infinite time | -60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration |
| AUC0-t | Area Under the Concentration-time curve from time zero to the last measurable concentration | -60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration |
| Cmax | Maximum concentration of the active substance in the blood plasma of participants during the observation period | -60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| AUC_%Extrap | Extrapolated Part Percentage of AUC0-inf | -60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration |
| Tmax | Time of maximum concentration observed |
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Inclusion Criteria:
Participants must meet all of the following criteria to be enrolled in the study:
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Anhui Medical University | Hefei | Anhui | 230601 | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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| HDG1901 | Drug | Participants will be given HDG1901 injection 0.25mg abdominal subcutaneous injection. |
|
| -60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration |
| t 1/2 | Elimination half life | -60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration |
| λz | The Volume of Distribution at Terminal Phase | -60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration |
| CL | Clearance Rate | -60minutes and 6, 12, 18, 24, 30, 36, 42, 48, 60, 72, 84, 96, 108, 120, 144, 336, 504, 672, 840 hours after administration |
| Safety and Immunogenicity | Adverse events and positive rate of anti-drug antibodies | AEs will be collected after assigning the ICF. Immunogenicity sample will be collected at -60 minutes and 336、840 hours after administration. |
| D004700 | Endocrine System Diseases |