An Accessorised Prefilled Syringe to an Autoinjector Pharmacokinetic Bridging Study of Tozorakimab

NCT06908577 | Completed Phase 1 FDA Drug

• 3 other identifiers: D9180C000062024-511840-222024-511840-22-00
• Study Type: interventional
• Target: 254
• Locations: 3 countries
• Sites: 4

Brief 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

Keywords

Anti-Interleukin (IL)-33 antibody; Human immunoglobulin G1 monoclonal antibody; Accessorised Prefilled Syringe (APFS); Autoinjector (AI); Respiratory and Inflammation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Time to reach maximum observed concentration (Tmax)

  From Day 1 to Day 113

• Terminal elimination half-life (t1/2λz)

  From Day 1 to Day 113

• Terminal rate constant (λz)

  From Day 1 to Day 113

• Apparent total body clearance (CL/F)

  From Day 1 to Day 113

• Apparent volume of distribution based on the terminal phase (Vz/F)

  From Day 1 to Day 113

Study Arms (2)

Treatment A: Tozorakimab (Test)

EXPERIMENTAL

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

Drug: Tozorakimab; Device: Autoinjector (AI) Device

Treatment B: Tozorakimab (Reference)

ACTIVE COMPARATOR

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

Drug: Tozorakimab; Device: Accessorised Prefilled Syringe (APFS) Device

Interventions

Tozorakimab DRUG

Tozorakimab will be administered as a single SC dose using an AI or APFS device on Day 1.

Also known as: MEDI3506

Treatment A: Tozorakimab (Test); Treatment B: Tozorakimab (Reference)

Autoinjector (AI) Device DEVICE

AI device will be used to administer single SC dose of tozorakimab on Day 1.

Treatment A: Tozorakimab (Test)

Accessorised Prefilled Syringe (APFS) Device DEVICE

APFS device will be used to administer single SC dose of tozorakimab on Day 1.

Treatment B: Tozorakimab (Reference)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (4)

Research Site

Glendale, California, 91206, United States

Location

Research Site

Baltimore, Maryland, 21225, United States

Location

Research Site

Berlin, 14050, Germany

Location

Research Site

Harrow, HA1 3UJ, United Kingdom

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 3, 2025
• Study Start: April 7, 2025
• Primary Completion: November 25, 2025
• Study Completion: November 25, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

US (2); DE (1); GB (1)