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The purpose of this study is to evaluate the pharmacokinetic (PK) similarity of AK112 (an anti-PD-1/VEGF bispecific antibody) from the proposed new manufacturing site and the approved original site in healthy male subjects.
Secondary objectives are to assess the safety, tolerability, and immunogenicity of AK112 from the proposed new manufacturing site and the approved original site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK112 (New Site) | Experimental | AK112 (New Site) 3mg/kg, will be administrated intravenously in 60±10 minutes. |
|
| AK112 (Original Site) | Active Comparator | AK112 (Original Site) 3mg/kg, will be administrated intravenously in 60±10 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK112 (New Site) | Drug | AK112 (New Site) 3mg/kg |
| |
| AK112 (Original Site) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve (AUC0-infinity) | From pre-dose to day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve (AUC0-t) | From pre-dose to day 43 | |
| Maximum plasma concentration (Cmax) | From pre-dose to day 43 | |
| Volume of distribution (Vd) |
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Inclusion Criteria:
Exclusion Criteria:
Eligibility is based on biological sex and reproductive risk criteria; gender identity is not a basis for exclusion.
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| Name | Affiliation | Role |
|---|---|---|
| Jinliang Chen, MD | Zhejiang Xiaoshan hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Xiaoshan Hospital | Zhejiang | Xiaoshan | China |
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| Drug |
AK112 (Original Site)3mg/kg |
|
| From pre-dose to day 43 |
| Clearance (CL) | From pre-dose to day 43 |
| Ratio of AUC0-t/AUC0-infinity | From pre-dose to day 43 |
| Time to maximum concentration (Tmax) | From pre-dose to day 43 |
| Half-life (t1/2) | From pre-dose to day 43 |
| Incidence and severity of adverse events (AEs) | Up to day 43 |
| Number and percentage of subjects with detectable ADA | From pre-dose to day 43 |