Completed

Tozorakimab Delivery Methods in Healthy Volunteers

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What is being tested

Tozorakimab

+ Autoinjector (AI) Device

+ Accessorised Prefilled Syringe (APFS) Device

DrugDevice
Who is being recruted

Inflammation

+ Pathologic Processes

+ Pathological Conditions, Signs and Symptoms

From 18 to 55 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: April 2025
See protocol details

Summary

Principal SponsorAstraZeneca
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 7, 2025

Actual date on which the first participant was enrolled.

This clinical trial is designed to understand how the drug Tozorakimab behaves in the body when administered through two different devices: a special prefilled syringe and an autoinjector, in healthy volunteers. It focuses on comparing the devices when the drug is injected into different areas of the body, specifically the abdomen, thigh, or upper arm. This study is crucial as it helps determine the most effective and comfortable method of delivering the medication, which can significantly enhance patient experience and adherence to treatment. Participants in this study are randomly assigned to receive the drug through one of the devices at one of the three different body sites. The study includes a screening period that can last up to 28 days to ensure participants meet the study criteria. Once enrolled, they will go through a treatment period of up to 9 days. After treatment, participants are monitored during a follow-up period lasting until 85 days, with a final check-up on Day 113. This setup helps researchers gather detailed information on how the drug is absorbed and processed in the body, ensuring both safety and effectiveness.

Official TitleA 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
NCT06908577
Principal SponsorAstraZeneca
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

254 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

InflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

Inclusion Criteria: * Healthy adults with suitable veins for cannulation or repeated venipuncture. * All females must have a negative pregnancy test at the screening visit and on admission. * Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception, in order to avoid pregnancy from the time of administration of study intervention until 16 weeks after administration of the study intervention (Day 113). * Females of non-childbearing potential must be confirmed at the screening visit. * Sexually active fertile male participants with partners of childbearing potential must adhere to the contraception methods from the time of administration of the study intervention until 16 weeks after administration of the study intervention (Day 113). * Have a body mass index (BMI) between 19 and 30 kg/m2 inclusive and weigh at least 55 kg and no more than 100 kg inclusive at screening and Day -1. * Intact normal skin without potentially obscuring tattoos, scars, etc., at the injection site. Exclusion Criteria: * History of any clinically significant disease or disorder which may either put the participant at risk because of participation in the study or influence the results of the study or the participant's ability to participate in the study. * Any clinically important medical/surgical procedure or trauma within 8 weeks of the screening visit, or any planned inpatient hospitalization during the study period. * Malignancy, current or within the past 5 years, suspected malignancy or undefined neoplasms. * Any abnormal laboratory values and vital signs. * History of known immunodeficiency disorder, including a positive test for human immunodeficiency virus (HIV)-1 or HIV-2. * History or treatment for hepatitis B or hepatitis C or any positive test result on screening for hepatitis B surface antigen (HBsAg), anti-hepatitis B core (HBc) antibodies, or anti-hepatitis C antibodies. * Evidence of currently active tuberculosis (TB) disease or use of any TB drug treatment in the past 12 months or latent TB infection. * Any clinically significant abnormalities on 12lead electrocardiogram (ECG) at the screening visit and/or admission (Day -1) to the Clinical Unit. * History of or ongoing severe clinically important allergy/hypersensitivity, or history of hypersensitivity to monoclonal or polyclonal antibodies. History of allergy or reaction to any formulation components of the investigational medicinal product (IMP). * Receipt of live attenuated vaccines within 30 days prior to randomization and receipt of COVID-19 or inactivated vaccines within 14 days prior to randomization. * Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months or 5 half-lives of time of dosing in this study, whichever is longer. * Receipt of any investigational biologic within 4 months or 5 half-lives prior to the date of dosing in this study, whichever is longer.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 4 locations

Suspended

Research Site

Glendale, United StatesOpen Research Site in Google Maps
Suspended

Research Site

Baltimore, United States
Suspended

Research Site

Berlin, Germany
Suspended

Research Site

Harrow, United Kingdom
Completed4 Study Centers
Tozorakimab Delivery Methods in Healthy Volunteers | PatLynk