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: 1. A screening period of 28 days 2. A Treatment period of 1 day 3. Ambulatory visits on scheduled days c. A final follow-up visit on Day 113 (Week 16)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Tozorakimab will be administered as a single SC dose on Day 1.
Research Site
Berlin, Germany
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).
Time frame: 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).
Time frame: 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).
Time frame: Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose).
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).
Time frame: 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)
To examine the t1/2 of two different dosage forms of tozorakimab (test and reference).
Time frame: 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).
Time frame: Day 1 (Pre-dose), Days 3, 4, 5, 7, 8, 9, 15, 29, 43, 57, 85 and 113 (Post-dose).
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Apparent total body clearance (CL/F)
To examine the CL/F of two different dosage forms of tozorakimab (test and reference).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Day 1 (Pre-dose), Days 29, 57 and 113 (Post-dose).