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This study is being done to find out if IBI355 is safe and tolerance in health volunteers. The study will test increasing single doses of IBI355 given to adult health volunteers. The goal is to confirmed the safety of the highest dose of IBI355 or to find out the highest dose of IBI35 that can be given to health volunteer that dose not cause unacceptable side effects. Different dose regimens will be evaluated. The pharmacokinetics and ADA of IBI355 will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI355 dose 1 | Experimental | IBI355 0.3mg/kg and placebo will be given to the subjects (3:2) |
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| IBI355 dose 4 | Experimental | IBI355 7.5mg/kg and placebo will be given to the subjects (6:2) |
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| IBI355 dose 6 | Experimental | IBI355 25mg/kg and placebo will be given to the subjects (6:2) |
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| IBI355 dose 7 | Experimental | IBI355 35mg/kg and placebo will be given to the subjects (6:2) |
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| IBI355 dose 2 | Experimental | IBI355 1mg/kg and placebo will be given to the subjects (6:2) |
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| IBI355 dose 3 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | placebo iv. once. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AE、SAE after receiving IBI 355 | week 0-12 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve, (AUC)、Maximum serum concentration of drug(Cmax)、Clearance (CL)、Apparent volume of distribution(V) and Half- life(t1/2)of IBI355 | week 0-12 |
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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 3mg/kg and placebo will be given to the subjects (6:2)
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| IBI355 dose 5 | Experimental | IBI355 15mg/kg and placebo will be given to the subjects (6:2) |
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| IBI355 | Drug | IBI355 iv. once. |
|