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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Tozorakimab; Device: Autoinjector (AI) Device; Device: Accessorised Prefilled Syringe (APFS) Device

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).

• Study Type: Interventional
• Enrollment (Actual): 254
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14050
    • Research Site
• United Kingdom
  • Harrow, United Kingdom, HA1 3UJ
    • Research Site
• United States
  • California
    • Glendale, California, United States, 91206
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21225
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment A: Tozorakimab (Test); Participants will receive a single SC dose of tozorakimab via AI device.	Drug: Tozorakimab; Tozorakimab will be administered as a single SC dose using an AI or APFS device on Day 1.; Other Names: MEDI3506; Device: Autoinjector (AI) Device; AI device will be used to administer single SC dose of tozorakimab on Day 1.
Active Comparator: Treatment B: Tozorakimab (Reference); Participants will receive a single SC dose of tozorakimab via APFS device with the same container closure as the AI.	Drug: Tozorakimab; Tozorakimab will be administered as a single SC dose using an AI or APFS device on Day 1.; Other Names: MEDI3506; Device: Accessorised Prefilled Syringe (APFS) Device; APFS device will be used to administer single SC dose of tozorakimab on Day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under concentration-time curve from time 0 to infinity (AUCinf) of tozorakimab	To compare the PK exposure following single SC administration of tozorakimab using AI and APFS devices in healthy participants.	From Day 1 to Day 113
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of tozorakimab	To compare the PK exposure following single SC administration of tozorakimab using AI and APFS devices in healthy participants.	From Day 1 to Day 113
Maximum observed drug concentration (Cmax) of tozorakimab	To compare the PK exposure following single SC administration of tozorakimab using AI and APFS devices in healthy participants.	From Day 1 to Day 113

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to reach maximum observed concentration (Tmax)	To assess additional PK parameters following single SC administration of tozorakimab using AI and APFS devices in healthy participants.	From Day 1 to Day 113
Terminal elimination half-life (t1/2λz)	To assess additional PK parameters following single SC administration of tozorakimab using AI and APFS devices in healthy participants.	From Day 1 to Day 113
Terminal rate constant (λz)	To assess additional PK parameters following single SC administration of tozorakimab using AI and APFS devices in healthy participants.	From Day 1 to Day 113
Apparent total body clearance (CL/F)	To assess additional PK parameters following single SC administration of tozorakimab using AI and APFS devices in healthy participants.	From Day 1 to Day 113
Apparent volume of distribution based on the terminal phase (Vz/F)	To assess additional PK parameters following single SC administration of tozorakimab using AI and APFS devices in healthy participants.	From Day 1 to Day 113
Number of participants with adverse events (AEs)	To assess the safety and tolerability following single SC administration of tozorakimab using AI and APFS devices in healthy participants.	From screening (Day -28 to -2) to follow up (Day 113)
Number of participants with positive anti-drug antibodies (ADA)	To evaluate the immunogenicity following single SC administration of tozorakimab using AI and APFS devices in healthy participants.	From Day 1 to Day 113

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Parexel

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2025
• Primary Completion (Actual): November 25, 2025
• Study Completion (Actual): November 25, 2025

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 3, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Human immunoglobulin G1 monoclonal antibody; Anti-Interleukin (IL)-33 antibody; Accessorised Prefilled Syringe (APFS); Autoinjector (AI); Respiratory and Inflammation
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation
• Other Study ID Numbers: D9180C00006; 2024-511840-22 (Other Identifier: EU CT Number); 2024-511840-22-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No