Study identifier:D9180C00011
ClinicalTrials.gov identifier:NCT06304961
EudraCT identifier:N/A
CTIS identifier:N/A
A Randomised, Single-dose, Parallel Group Study in Healthy Volunteers to Assess the Relative Bioavailability of Two Different Dosage Forms for Tozorakimab via Subcutaneous Administration
Healthy Participants
Phase 1
Yes
-
All
46
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
-
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: a. A screening period of 28 days b. A Treatment period of 1 day c. Ambulatory visits on scheduled days c. A final follow-up visit on Day 113 (Week 16)
Location
Location
Berlin, Germany, 14050
Arms | Assigned Interventions |
---|---|
Experimental: Tozorakimab Dosage form A (Test) Participants will receive a single dose of Tozorakimab Dosage form A via subcutaneous (SC) injection. | Biological/Vaccine: Tozorakimab Tozorakimab will be administered as a single SC dose on Day 1. |
Experimental: Tozorakimab Dosage form B (Reference) Participants will receive a single dose of Tozorakimab Dosage form B via SC injection. | Biological/Vaccine: Tozorakimab Tozorakimab will be administered as a single SC dose on Day 1. |
This information is not intended to replace the informed medical advice or medical treatments of a healthcare professional. Only a physician can determine if a specific medicine is the correct treatment for a particular patient. If you have questions regarding any information contained in this site, you must consult a suitably qualified healthcare professional. Before prescribing any AstraZeneca products, Healthcare Professionals should view their country specific information.