Comparing two injection methods for a new medication in healthy adults

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

This study is testing two different ways to give a new medication to healthy adults to see which method works better.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 252 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: AstraZeneca (Industry-sponsored)
• Drugs / interventions: tozorakimab
• Locations: 4 sites (Glendale, California and 3 other locations)
• Trial ID: NCT06908577 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the pharmacokinetics of tozorakimab, an anti-IL-33 antibody, by comparing its administration through an autoinjector and an accessorised prefilled syringe in healthy participants. It is a randomized, open-label, parallel group Phase 1 study involving multiple centers. Participants will be assigned to one of six combinations of injection devices and sites, with a screening period of up to 28 days, a treatment period of up to 9 days, and follow-up lasting until 113 days post-treatment.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18-65 with a BMI between 19 and 30 kg/m2.

Not a fit: Patients with underlying health conditions or those outside the specified BMI range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the delivery methods for tozorakimab, potentially improving patient experience and medication adherence.

How similar studies have performed: Previous studies have shown promise in pharmacokinetic evaluations of similar monoclonal antibodies, suggesting this approach may yield valuable insights.

Eligibility 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.

Where this trial is running

Glendale, California and 3 other locations

• Research Site — Glendale, California, United States (Recruiting)
• Research Site — Baltimore, Maryland, United States (Recruiting)
• Research Site — Berlin, Germany (Not_yet_recruiting)
• Research Site — Harrow, United Kingdom (Not_yet_recruiting)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions Healthy Participants; Anti-Interleukin-33 antibody; Human immunoglobulin G1 monoclonal antibody; Accessorised Prefilled Syringe; Autoinjector; Respiratory and Inflammation