An Accessorised Prefilled Syringe to an Autoinjector Pharmacokinetic Bridging Study of Tozorakimab
NCT06908577 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 254
Last updated 2025-12-02
Summary
The purpose of this study is to compare the pharmacokinetic (PK) exposures of a single subcutaneous (SC) dose of tozorakimab administered using AI or APFS in healthy participants.
Conditions
- Healthy Participants
Interventions
- DRUG
-
Tozorakimab
Tozorakimab will be administered as a single SC dose using an AI or APFS device on Day 1.
- DEVICE
-
Autoinjector (AI) Device
AI device will be used to administer single SC dose of tozorakimab on Day 1.
- DEVICE
-
Accessorised Prefilled Syringe (APFS) Device
APFS device will be used to administer single SC dose of tozorakimab on Day 1.
Sponsors & Collaborators
-
Parexel
collaborator INDUSTRY - lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-04-07
- Primary Completion
- 2025-11-25
- Completion
- 2025-11-25
- FDA Drug
- Yes
Countries
- United States
- Germany
- United Kingdom
Study Locations
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