NCT06908577

An Accessorised Prefilled Syringe to an Autoinjector Pharmacokinetic Bridging Study of Tozorakimab

A Multiple Centre, Randomised, Open-label, Parallel Group, Phase I Pharmacokinetic Comparability Study of Tozorakimab Administered Using an Accessorised Prefilled Syringe (APFS) or an Autoinjector (AI) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 254 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a multiple center, randomized, open-label, parallel group, Phase 1 study. Participants will be randomized 1:1:1:1:1:1 to one of the 6 combinations of the devices (APFS or AI devices) and one of three injection sites (abdomen, thigh, or upper arm.). The study includes: * A screening period of up to 28 days. * A treatment period (up to 9 days). * A follow-up period till 85 days. * A final follow-up visit on Day 113 (Week 16).

Conditions

• Healthy Participants

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-04-07
• Primary completion: 2025-11-25
• Completion: 2025-11-25
• First posted: 2025-04-03
• Last updated: 2025-12-02

Locations

4 sites across 3 countries: United States, Germany, United Kingdom

Regulatory

• FDA-regulated drug study