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The purpose of this study is to establish PK similarity in the treatment of BAT1706 and comparators.
This is a Phase I, randomized, double-blind, single-dose, 3-arm parallel group study to compare the PK, and to evaluate the safety, tolerability and immunogenicity, of BAT1706, EU-Avastin and US-Avastin after a single IV infusion in healthy adult male subjects.
A total of 129 healthy male subjects who meet the required entry criteria will be randomly assigned to one of three treatment groups in a 1:1:1 ratio to receive a single IV infusion of either BAT1706, EU-Avastin or US-Avastin. A total of 117 evaluable subjects are required.
Initially, subjects will be administered the study drug in staggered groups; the first group will comprise 3 subjects, the second group 6 subjects and the third group 9 subjects. Within each group subjects will be randomized to ensure equal numbers of subjects receive each of the three treatments.
There will be at least 48 hours between administrations of study drug to each group. Prior to administration of study drug to the next group, the safety and tolerability findings of the preceding group will be reviewed by the Principal Investigator. The next group will be dosed provided there are no serious or unexpected drug-related safety issues. Each subject will be required to remain in the clinical center for 48 hours after dosing for safety evaluation.
After the first 3 groups have been evaluated, the Principal Investigator will decide whether to proceed with continuous enrolment according to the clinical center capability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAT1706 | Experimental | BAT1706 injection |
|
| EU-sourced Avastin | Active Comparator | EU-sourced Avastin |
|
| US-sourced Avastin | Active Comparator | US-sourced Avastin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAT1706 injection | Biological | 1mg/kg, IV on day 1 |
| |
| EU-sourced Avastin |
| Measure | Description | Time Frame |
|---|---|---|
| area under curve (AUC)0~∞ | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris Wynne, Medical Doc | Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christchurch Clinical Studies Trust Ltd (CCST) | Christchurch | 8011 | New Zealand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31016568 | Derived | Wu X, Wynne C, Xu C, Gan Y, Wang C, Thomas BE, Yu JC, Li S, Zhang L. A Global Phase I Clinical Study Comparing the Safety and Pharmacokinetics of Proposed Biosimilar BAT1706 and Bevacizumab (Avastin(R)) in Healthy Male Subjects. BioDrugs. 2019 Jun;33(3):335-342. doi: 10.1007/s40259-019-00352-7. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 5, 2020 | |
| Reset | Dec 3, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 5, 2020 | Dec 3, 2020 |
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| Biological |
1mg/kg, IV on day 1 |
|
| US-sourced Avastin | Biological | 1mg/kg, IV on day 1 |
|