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The study has been designed as a randomised, parallel-group, double-blind, 3 arm study to investigate the comparative pharmacokinetics, safety, immunogenicity and tolerability between AVT80 and Entyvio in healthy volunteers.
The study will consist of a screening period, a treatment and assessment period and an End of Study visit. Eligibility for the study will be determined during a screening period. Subjects who meet the eligibility criteria will be randomised to receive a single dose of either AVT80, geographical region 1 Entyvio or geographical region 2 Entyvio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AVT80 | Experimental | Single subcutaneous administration of AVT80 |
|
| Geographical region 1 Entyvio | Active Comparator | Single subcutaneous administration of Geographical region 1 Entyvio |
|
| Geographical region 2 Entyvio | Active Comparator | Single subcutaneous administration of Geographical region 2 Entyvio |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVT80 | Biological | Single subcutaneous injection of AVT80 (108mg) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate PK similarity of AVT80 with geographical region 1 Entyvio and geographical region 2 Entyvio and between geographical region 1 Entyvio and geographical region 2 Entyvio | PK endpoint of Cmax. | Day Zero to Day 126 |
| To demonstrate PK similarity of AVT80 with geographical region 1 Entyvio and geographical region 2 Entyvio and between geographical region 1 Entyvio and geographical region 2 Entyvio | PK endpoint of AUC0-inf. | Day Zero to Day 126 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eveline Schurink | Alvotech Swiss AG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veritus Research Pty Ltd | Bayswater | Australia | ||||
| Investigational Site 0002 |
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| Geographical region 1 Entyvio |
| Biological |
Single subcutaneous injection of Geographical region 1 Entyvio (108mg) |
|
| Geographical region 2 Entyvio | Biological | Single subcutaneous injection of Geographical region 2 Entyvio (108mg) |
|
| Auckland |
| New Zealand |
| NZCR | Christchurch | 8011 | New Zealand |