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

Launched by ASTRAZENECA · Apr 2, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to study a new medication called tozorakimab and how well it works when given in two different ways: using an autoinjector (a device that automatically injects the medication) or a prefilled syringe. The goal is to see how the body absorbs this medication when healthy adults receive a single dose of it under the skin.

To participate in this trial, you need to be a healthy adult aged between 18 and 65, with a body weight between 55 and 100 kg. Women must have a negative pregnancy test and agree to use effective birth control during the study. Participants will be monitored closely, and those with certain health conditions or recent medical procedures may not be eligible. If you join this trial, you can expect to have regular check-ups and provide some information about your health, but overall, the study aims to ensure your safety and well-being throughout the process.

Gender

ALL

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.