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This is a randomized, double-blinded, controlled Phase 1 study to compare the pharmacokinetic, safety and immunogenicity of QL2106 versus Tremfye®(Guselkumab) in healthy subjects after a single dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL2106 | Experimental |
| |
| Tremfye® | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL2106 | Drug | 100mg/1 ml; single dose; subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics Endpoint | Peak plasma concentration (Cmax) | 0-113 days |
| Pharmacokinetics Endpoint | Area under the plasma concentration versus time curve (AUC0-inf) | 0-113 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing GoBroad Hospital | Beijing | Beijing Municipality | 100000 | China |
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| Tremfye® |
| Drug |
100mg/1 ml; single dose; subcutaneous injection |
|