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The study will assess the relative bioavailability between two dosage forms of tozorakimab (test dosage form and reference dosage form) and to assess the pharmacokinetic (PK) profiles of both dosage forms.
This is a phase I, randomised, open-label, single-dose, single-centre, parallel group study investigating the relative bioavailability of two dosage forms of tozorakimab (test dosage form and reference dosage form).
The study will comprise of:
c. A final follow-up visit on Day 113 (Week 16)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tozorakimab Dosage form A (Test) | Experimental | Participants will receive a single dose of Tozorakimab Dosage form A via subcutaneous (SC) injection. |
|
| Tozorakimab Dosage form B (Reference) | Experimental | Participants will receive a single dose of Tozorakimab Dosage form B via SC injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tozorakimab | Biological | Tozorakimab will be administered as a single SC dose on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from time 0 to infinity (AUCinf) | To evaluate the relative bioavailability of two different dosage forms of tozorakimab (test and reference). | Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose). |
| Area under the concentration-curve from time 0 to the last quantifiable concentration (AUClast) | To evaluate the relative bioavailability of two different dosage forms of tozorakimab (test and reference). | Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose). |
| Maximum observed drug concentration (Cmax) | To evaluate the relative bioavailability of two different dosage forms of tozorakimab (test and reference). | Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose). |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach peak or maximum observed concentration following tozorakimab administration (tmax) | To examine the tmax of two different dosage forms of tozorakimab (test and reference). | Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose). |
| Terminal elimination half-life (t1/2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Berlin | 14050 | Germany |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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To examine the t1/2 of two different dosage forms of tozorakimab (test and reference). |
| Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose). |
| Terminal rate constant (λz) | To examine the λz of of two different dosage forms of tozorakimab (test and reference). | Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose). |
| Apparent total body clearance (CL/F) | To examine the CL/F of two different dosage forms of tozorakimab (test and reference). | Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose). |
| Apparent volume of distribution based on the terminal phase (Vz/F) | To examine the Vz/F of two different dosage forms of tozorakimab (test and reference). | Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose). |
| Number of participants with adverse events (AEs) | To assess the safety and tolerability of a single dose of tozorakimab administered subcutaneously via two different dosage forms in healthy participants. | From screening (Day -28) to last follow-up visit (Day 113- approximately 21 weeks). |
| Number of participants with presence of Anti-Drug Anitbodies (ADAs) | To evaluate the immunogenicity of a single dose of tozorakimab administered subcutaneously via two different dosage forms in healthy participants. | Day 1 (Pre-dose), Days 29, 57 and 113 (Post-dose). |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |