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This is a randomized, double-blinded, controlled Phase I study of CMAB809 administered by intravenous infusion. This study will characterize the pharmacokinetic, safety and immunogenicity of CMAB809 versus Trastuzumab(Herceptin) in healthy male subjects after a single dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CMAB809 | Experimental |
| |
| Trastuzumab | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMAB809 | Drug | CMAB809 will be administered by IV infusion at a single dose of 6mg/kg. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve [AUC] | Area under the concentration-time curve [AUC] from 0 to the last time point selected of CMAB809 | pre-dose, hour1.5, hour3, hour8, hour24, hour48, hour96, hour168, hour336, hour504, hour672, hour1008, hour1344, hour1680 post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum Serum Concentration(Cmax) of CMAB809 | pre-dose, hour1.5, hour3, hour8, hour24, hour48, hour96, hour168, hour336, hour504, hour672, hour1008, hour1344, hour1680 post-dose |
| AUC0-∞ | Area under the concentration-time curve from 0 to inf(AUC0-∞) of CMAB809 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with Adverse Events | Percentage of participants with Adverse Events (AEs) according to National Cancer Institute Common Terminology Criteria for AEs, Version 5.0(NCI CTCAE V5.0) Common Terminology Criteria for AEs, Version 5.0 (NCI CTCAE V5.0) | Up to 71 days after administration |
| anti-drug antibodies(ADA) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jingying Jia, MSC | Shanghai Xuhui Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Shanghai | Shanghai Municipality | 200031 | China |
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| ID | Term |
|---|---|
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Trastuzumab |
| Drug |
Trastuzumab will be administered by IV infusion at a single dose of 6mg/kg. |
|
| pre-dose, hour1.5, hour3, hour8, hour24, hour48, hour96, hour168, hour336, hour504, hour672, hour1008, hour1344, hour1680 post-dose |
| Tmax | The time of maximum blood concentration after administration(Tmax) of CMAB809 | pre-dose, hour1.5, hour3, hour8, hour24, hour48, hour96, hour168, hour336, hour504, hour672, hour1008, hour1344, hour1680 post-dose |
| CL | Total clearance after bioavailability correction(CL) of CMAB809 | pre-dose, hour1.5, hour3, hour8, hour24, hour48, hour96, hour168, hour336, hour504, hour672, hour1008, hour1344, hour1680 post-dose |
| T1/2 | Half-life(T1/2) of CMAB809 | pre-dose, hour1.5, hour3, hour8, hour24, hour48, hour96, hour168, hour336, hour504, hour672, hour1008, hour1344, hour1680 post-dose |
| Vd | Apparent volume of distribution corrected for bioavailability(Vd) of CMAB809 | pre-dose, hour1.5, hour3, hour8, hour24, hour48, hour96, hour168, hour336, hour504, hour672, hour1008, hour1344, hour1680 post-dose |
The number of subjects will be summarized |
| pre-dose, week3, week5 and week11 post-dose |
| anti-drug antibodies(ADA) | The percentage of subjects will be summarized | pre-dose, week3, week5 and week11 post-dose |
| Neutralization antibodies(Nab) | The number of subjects will be summarized | pre-dose, week3, week5 and week11 post-dose |
| Neutralization antibodies(Nab) | The percentage of subjects will be summarized | pre-dose, week3, week5 and week11 post-dose |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |