Tozorakimab for Healthy Subjects

Recruiting at 3 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Must not be taking: TB drugs, Live vaccines

Disqualifiers: Malignancy, Immunodeficiency, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 9 days

252 Participants Needed

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.

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

Group I: Treatment A: Tozorakimab (Test) Experimental Treatment 2 Interventions

Participants will receive a single SC dose of tozorakimab via AI device.

Group II: Treatment B: Tozorakimab (Reference) Active Control 2 Interventions

Participants will receive a single SC dose of tozorakimab via APFS device with the same container closure as the AI.

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

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

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland