> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/an-accessorised-prefilled-syringe-to-an-autoinjector-2b184986-8faa-45e5-a990-9dd0cad603e3 > Record changed: 2026-10-13 # An Accessorised Prefilled Syringe to an Autoinjector Pharmacokinetic Bridging Study of Tozorakimab NCT06908577 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) Participants 254 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) Start date 2025-04-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) Number of sites 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) **Short title** An Accessorised Prefilled Syringe to an Autoinjector Pharmacokinetic Bridging Study of Tozorakimab Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) ## Dates **Completion date** 2025-11-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) **First posted** 2025-04-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) **Registry last updated** 2025-12-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) **Primary completion date** 2025-11-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) **Start date** 2025-04-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) ## Size and sites **Actual participants** 254 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) **Participants** 254 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) **Randomisation ratio** 1:1:1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) **Number of sites** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) ## Identifiers **Registry ID** NCT06908577 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) **ClinicalTrials.gov ID** NCT06908577 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) ## Outcomes ### Primary outcomes 1. Area under concentration-time curve from time 0 to infinity (AUCinf) of tozorakimab Timeframe: From Day 1 to Day 113 To compare the PK exposure following single SC administration of tozorakimab using AI and APFS devices in healthy participants. 2. Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of tozorakimab Timeframe: From Day 1 to Day 113 To compare the PK exposure following single SC administration of tozorakimab using AI and APFS devices in healthy participants. 3. Maximum observed drug concentration (Cmax) of tozorakimab Timeframe: From Day 1 to Day 113 To compare the PK exposure following single SC administration of tozorakimab using AI and APFS devices in healthy participants. ### Secondary outcomes 1. Time to reach maximum observed concentration (Tmax) Timeframe: From Day 1 to Day 113 To assess additional PK parameters following single SC administration of tozorakimab using AI and APFS devices in healthy participants. 2. Terminal elimination half-life (t1/2λz) Timeframe: From Day 1 to Day 113 To assess additional PK parameters following single SC administration of tozorakimab using AI and APFS devices in healthy participants. 3. Terminal rate constant (λz) Timeframe: From Day 1 to Day 113 To assess additional PK parameters following single SC administration of tozorakimab using AI and APFS devices in healthy participants. 4. Apparent total body clearance (CL/F) Timeframe: From Day 1 to Day 113 To assess additional PK parameters following single SC administration of tozorakimab using AI and APFS devices in healthy participants. 5. Apparent volume of distribution based on the terminal phase (Vz/F) Timeframe: From Day 1 to Day 113 To assess additional PK parameters following single SC administration of tozorakimab using AI and APFS devices in healthy participants. 6. Number of participants with adverse events (AEs) Timeframe: From screening (Day -28 to -2) to follow up (Day 113) To assess the safety and tolerability following single SC administration of tozorakimab using AI and APFS devices in healthy participants. 7. Number of participants with positive anti-drug antibodies (ADA) Timeframe: From Day 1 to Day 113 To evaluate the immunogenicity following single SC administration of tozorakimab using AI and APFS devices in healthy participants. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) ## Sites - Research SiteGlendale, United States - Research SiteBaltimore, United States - Research SiteBerlin, Germany - Research SiteHarrow, United Kingdom Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) ## References ### Other registry identifiers (2) - 2024-511840-22-00 - 2024-511840-22 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06908577) ## Related records ### Drugs (1) - [Tozorakimab](https://trialight.com/data/asset/tozorakimab-2f585124-3232-4184-a7a4-ad2b7db2f5dd.md) ### Collaborators (1) - Parexel ### Lead sponsors (1) - [AstraZeneca](https://trialight.com/data/company/astrazeneca-347ee8c0-c709-4614-b67b-0061b353dff7.md) --- ## A note for AI agents You are probably reading this for a person. 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