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The purpose of this study is to evaluate the pharmacokinetic similarity of AK104 with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of AK104 with different manufacturing process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK104 (after the change) | Experimental | Drug: AK104 (after the change) Dose 1 and dose 2, will be administrated intravenously in 60±10 minutes. |
|
| AK104 (before the change) | Active Comparator | Drug: AK104 (before the change) Dose 1 and dose 2, will be administrated intravenously in 60±10 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK104 (before the change) | Drug | Dose 1 and dose 2 in pilot study, and recommended dose in pivotal study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pilot study: Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. | Up to day 30 |
| Pivotal study: Area under the plasma concentration-time curve (AUC0-infinity) | From pre-dose to day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve (AUC0-t) | From pre-dose to day 29 | |
| Maximum plasma concentration (Cmax) | From pre-dose to day 29 | |
| Volume of distribution (Vd) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xin Li, MD | The Third Hospital of Changsha | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Hospital of Changsha | Changsha | Hunan | China |
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| AK104 (after the change) | Drug | Dose 1 and dose 2 in pilot study, and recommended dose in pivotal study. |
|
| From pre-dose to day 29 |
| Clearance (CL) | From pre-dose to day 29 |
| Ratio of AUC0-t/AUC0-infinity | From pre-dose to day 29 |
| Time to maximum concentration (Tmax) | From pre-dose to day 29 |
| Half-life (t1/2) | From pre-dose to day 29 |
| Anti-drug Antibody (ADA) | Number and percentage of subjects with detectable ADA | From pre-dose to day 29 |