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This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of IBI355 in Healthy volunteers. This study also aims to evaluate the anti-Drug antibody after multiple ascending doses of IBI355 in Healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI355 dose-3 | Experimental | IBI355 15mg/kg and placebo will be given to the subjects every 4 weeks (6:2) |
|
| IBI355 dose-1 | Experimental | IBI355 1mg/kg and placebo will be given to the subjects every 4 weeks (6:2) |
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| IBI355 dose-4 | Experimental | IBI355 30mg/kg and placebo will be given to the subjects every 4 weeks (6:2) |
|
| IBI355 dose-2 | Experimental | IBI355 7.5mg/kg and placebo will be given to the subjects every 4 weeks (6:2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | IBI355 7.5mg/kg Q4W |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events and serious adverse events | Up to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the Curve(AUC) of multi-dose of IBI355 | Up to week 12 | |
| Peak serum concentration(Cmax) of multi-dose of IBI355 | Up to week 12 | |
| Clearance (CL) of multi-dose of IBI355 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aerospace Center Hospital | Beijing | Beijing Municipality | 100049 | China |
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| IBI355 | Drug | IBI355 1mg/kg Q4W |
|
| Up to week 12 |
| Half-life (t1/2) of multi-dose of IBI355 | Up to week 12 |
| The ratio of Anti-drug antibody of multi-dose of IBI355 | Up to week 24 |