252 Participants Needed

Tozorakimab for Healthy Subjects

Recruiting at 3 trial locations
AC
Overseen ByAstraZeneca Clinical Study Information Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study is for healthy participants, it's possible that you may need to avoid certain medications. Please consult with the study coordinators for specific guidance.

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for healthy adults with good veins for blood draws, a BMI between 19 and 30 kg/m2, and weight between 55-100 kg. Women must not be pregnant or breastfeeding and use contraception if of childbearing potential. Men with partners who can bear children must also use contraception.

Inclusion Criteria

I am not pregnant, as confirmed by tests.
I am not able to have children, as confirmed during screening.
I have veins suitable for repeated needle insertions.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive a single subcutaneous dose of tozorakimab using either an AI or APFS device

9 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

85 days

Final Follow-up Visit

A final follow-up visit to assess long-term safety and PK parameters

16 weeks

Treatment Details

Interventions

  • Tozorakimab
Trial Overview The study aims to compare how the body absorbs Tozorakimab when given by an autoinjector (AI) versus an accessorised prefilled syringe (APFS). Participants will receive a single subcutaneous dose using one of these devices.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment A: Tozorakimab (Test)Experimental Treatment2 Interventions
Participants will receive a single SC dose of tozorakimab via AI device.
Group II: Treatment B: Tozorakimab (Reference)Active Control2 Interventions
Participants will receive a single SC dose of tozorakimab via APFS device with the same container closure as the AI.

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Parexel

Industry Sponsor

Trials
322
Recruited
137,000+
Peyton Howell profile image

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith profile image

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

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