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This is a single-center, randomized, open, six-sequence, three-period crossover phase I clinical trial in healthy subjects to compare the PK/PD and safety profiles of single dose of HR20014, INS068, and INS062. In this study, 12 subjects were randomly assigned to 6 administration sequences in a ratio of 1:1:1:1:1:1, and HR20014, INS068 or INS062 injection were given subcutaneously three times before and after each sequence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group sequence 1 | Experimental | Subjects were given HR20014, INS068, or INS062 injections subcutaneously once in three cycles. The interval of each dosing visit was 7 to 21 days. |
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| Treatment group sequence 2 | Experimental | Subjects were given HR20014, INS062, or INS068 injections subcutaneously once in three cycles. The interval of each dosing visit was 7 to 21 days. |
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| Treatment group sequence 3 | Experimental | Subjects were given INS068, HR20014, or INS062 injections subcutaneously once in three cycles. The interval of each dosing visit was 7 to 21 days. |
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| Treatment group sequence 4 | Experimental | Subjects were given INS068, INS062, or HR20014 injections subcutaneously once in three cycles. The interval of each dosing visit was 7 to 21 days. |
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| Treatment group sequence 5 | Experimental | Subjects were given INS062, HR20014, or INS068 injections subcutaneously once in three cycles. The interval of each dosing visit was 7 to 21 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INS062 injection、INS068 injection、HR20014 injection | Drug | INS062 injection:A single dose of 0.4 DU/kg is administered to healthy subjects. INS068 injection:A single dose of 0.4 U/kg is administered to healthy subjects. HR20014 injection:A single dose of 0.4 U/kg is administered to healthy subjects. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the Glucose Infusion Rate (GIR) - time curve (Only for HR20014 and INS068) | 0 hour to 6 hours after dosing | |
| Area under the Glucose Infusion Rate (GIR) - time curve (Only for HR20014 and INS062) | 6 hours to 24 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the Glucose Infusion Rate (GIR) - time curve | Based on the absolute dose and concentration of INS068 | 0 hour to 96 hours after dosing |
| Maximum concentration of INS068 | Based on the absolute dose and concentration of INS068 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The second affiliated hospital of Anhui Medical University | Hefei | Anhui | 230601 | China |
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The study was a single-center, randomized, open, six-sequence, three-cycle crossover phase I study in healthy subjects. The objective of this trial was to compare the PK/PD and safety of HR20014, INS068 and INS062 in a single subcutaneous injection of the same dose.
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| Treatment group sequence 6 | Experimental | Subjects were given INS062, INS068, or HR20014 injections subcutaneously once in three cycles. The interval of each dosing visit was 7 to 21 days. |
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| 0 hour to 96 hours after dosing |
| Area under the Glucose Infusion Rate (GIR) - time curve | Based on the absolute dose and concentration of INS062 | 0 hour to 10 hours after dosing |
| Maximum concentration of INS062 | Based on the absolute dose and concentration of INS062 | 0 hour to 10 hours after dosing |
| Incidence and severity of adverse events (AEs) | from screening to 7-21 days after the last dosing |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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