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The objective of the study is to assess the safety, tolerability and pharmacokinetics of HR011408 at two formulations in healthy subject.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort one: Low dose | Experimental | Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively |
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| Cohort two: Medium dose | Experimental | Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively |
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| Cohort three: high dose | Experimental | Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR011408 injection | Drug | Drug: HR011408 injection (formulation A), administered subcutaneously. Drug: HR011408 injection (formulation B), administered subcutaneously. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs) | The incidence of adverse events will be collected and the safety of HR011408 will be assessed | from Day1 to Day15 |
| Area under the concentration-time curve (AUC) | Area under the concentration-time curve (AUC) | from 0 to 10 hours after dose administration |
| Maximum observed concentration (Cmax) | Maximum observed concentration (Cmax) | from 0 to 10 hours after dose administration |
| Time to maximum observed concentration (Tmax) | Time to maximum observed concentration (Tmax) | from 0 to 10 hours after dose administration |
| Elimination half-life (t1/2) | Elimination half-life (t1/2) | from 0 to 10 hours after dose administration |
| Time to 50% maximum observed concentration (time to 50% Cmax) | Time to 50% maximum observed concentration (time to 50% Cmax) | from 0 to 10 hours after dose administration |
| Onset of appearance | First time point after dose administration when concentration reaches lower limit of quantification (LLOQ) | from 0 to 10 hours after dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of development of Anti-drug Antibodies (ADAs) | Incidence of Anti-drug Antibodies (ADAs) will be assessed | from Day1 to Day15 after dose administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Provincial Qianfoshan Hospital | Jinan | Shandong | 250014 | China |
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Crossover Assigned to HR011408(formulation A) or HR011408(formulation B)
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