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

No results posted yet for this study

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
  • AstraZeneca

    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

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06908577 on ClinicalTrials.gov