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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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This is a study to compare PK of tezepelumab exposure in healthy subjects by using vial and syringe, APFS, and AI.
This study will be a single center, randomized, open label, parallel group study designed to compare tezepelumab PK exposure in healthy subjects following single subcutaneous (SC) administration of a fixed dose of tezepelumab by using vial and syringe, APFS, or AI. A total of 315 subjects will be randomized to receive a single, fixed dose of tezepelumab administered SC using vial-and-syringe, APFS, or AI at 1 of 3 injection sites: abdomen, thigh or upper arm. Separate randomization lists will be produced for each weight group (50 to < 70 kg, 70 to < 80 kg, 80 to 90 kg), and within each of the 3 weight groups, subjects will be randomized 1:1:1:1:1:1:1:1:1 to 1 of the 9 combinations of treatment (vial-and-syringe, APFS, or AI) with injection site (abdomen, thigh, upper arm). Within each weight group, at least 36 subjects will be randomized resulting in at least 12 subjects per treatment group (device) within each weight group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tezepelumab via Vial-and-syringe | Experimental | Participants will be randomized to a single dose of tezepelumab via SC administration with Vial-and-syringe |
|
| Tezepelumab via APFS | Experimental | Participants will be randomized to a single dose of tezepelumab via SC administration with APFS |
|
| Tezepelumab via AI | Experimental | Participants will be randomized to a single dose of tezepelumab via SC administration with AI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tezepelumab | Biological | Tezepelumab subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| The area under the time concentration curves from zero to infinity (AUCinf) | To compare the AUCinf following single SC administration of tezepelumab using Vial-and-syringe, APFS, and AI. | At Days 1, 2, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 71, 85, 99, and 113 |
| The maximum observed concentration (Cmax) | To compare the Cmax following single SC administration of tezepelumab using vial-and-syringe, APFS, and AI. | At Days 1, 2, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 71, 85, 99, and 113 |
| Measure | Description | Time Frame |
|---|---|---|
| The areas under the time concentration curves from zero to last observation (AUClast) | To determine the AUClast following single dose SC administration of tezepelumab using vial and syringe, APFS and AI. | At Days 1, 2, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 71, 85, 99, and 113 |
| Time to Cmax (tmax) |
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Inclusion Criteria:
Exclusion Criteria:
History of any clinically significant disease or disorder.
History of anaphylactic reaction to biologic therapy.
Acute upper or lower respiratory infection requiring antibiotics or antiviral medications.
History of tuberculosis.
History of known immunodeficiency disorder, including a positive human immunodeficiency virus, or the subject is taking antiretroviral medications.
Receipt of any marketed or investigational biologic agent within 4 months or 5 half lives prior to the Screening Visit.
Current smokers or those who have smoked or used nicotine products including e-cigarettes within the 3 months prior to the Screening Visit.
History of cancer:
Subjects who have had basal cell carcinoma or in situ carcinoma of the cervix are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to the Screening Visit.
Subjects who have had other malignancies including breast cancer are eligible provided that curative therapy was completed at least 5 years prior to the Screening Visit.
Subjects who have previously received tezepelumab.
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Rainard Fuhr | Parexel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Berlin | 14050 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34358701 | Derived | Corren J, Ambrose CS, Salapa K, Roseti SL, Griffiths JM, Parnes JR, Colice G. Efficacy of Tezepelumab in Patients with Severe, Uncontrolled Asthma and Perennial Allergy. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4334-4342.e6. doi: 10.1016/j.jaip.2021.07.045. Epub 2021 Aug 3. | |
| 33380362 | Derived | Zheng Y, Abuqayyas L, Megally A, Fuhr R, Salapa K, Downie J, Colice G. Tezepelumab Pharmacokinetics, Safety, and Tolerability After Administration via Vial-and-syringe, Accessorized Prefilled Syringe, or Autoinjector: A Randomized Trial in Healthy Volunteers. Clin Ther. 2021 Jan;43(1):142-155.e5. doi: 10.1016/j.clinthera.2020.11.014. Epub 2020 Dec 27. |
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To determine time to Cmax (tmax) following single dose SC administration of tezepelumab using vial and syringe, APFS and AI. |
| At Days 1, 2, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 71, 85, 99, and 113 |
| Terminal phase elimination half life (t½λz) | To determine t½λz following single dose SC administration of tezepelumab using vial and syringe, APFS and AI. | At Days 1, 2, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 71, 85, 99, and 113 |
| Apparent systemic clearance (CL/F) | To determine CL/F following single dose SC administration of tezepelumab using vial and syringe, APFS and AI. | At Days 1, 2, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 71, 85, 99, and 113 |
| Apparent terminal phase volume of distribution (Vz/F) | To determine Vz/F estimated by non compartmental analysis following single dose SC administration of tezepelumab using vial and syringe, APFS and AI. | At Days 1, 2, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 71, 85, 99, and 113 |
| Presence of ADAs to tezepelumab | To evaluate the immunogenicity of single dose tezepelumab administered SC using Vial-and-syringe, APFS and AI | At Day 1, 15, 29, 71 and 113 |
| Number of subjects with adverse events (AEs)/ serious adverse events (SAEs) | To determine the number of subjects with AEs/SAEs following single dose SC administration of tezepelumab using vial and syringe, APFS and AI. | From screening (Day -28) to follow up period (Day 113) |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000622721 | tezepelumab |
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