Healthy ParticipantsPhase 1NCT06908577
An Accessorised Prefilled Syringe to an Autoinjector Pharmacokinetic Bridging Study of Tozorakimab
A Phase 1 study testing Tozorakimab, Autoinjector (AI) Device and Accessorised Prefilled Syringe (APFS) Device in people with Healthy Participants, run by AstraZeneca at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Tozorakimab, Autoinjector (AI) Device and Accessorised Prefilled Syringe (APFS) Device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 7 Apr 2025to 25 Nov 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
United States2 sites
Research Site
Baltimore, Maryland, 21225
Research Site
Glendale, California, 91206
About this study
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
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.
Read the 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).
- Conditions
- Healthy Participants
- Being tested
- Tozorakimab, Autoinjector (AI) Device, Accessorised Prefilled Syringe (APFS) Device
- Keywords
- Anti-Interleukin (IL)-33 antibody, Human immunoglobulin G1 monoclonal antibody, Accessorised Prefilled Syringe (APFS), Autoinjector (AI), Respiratory and Inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TozorakimabDrug
Also called MEDI3506
Tozorakimab will be administered as a single SC dose using an AI or APFS device on Day 1.
Autoinjector (AI) DeviceDevice
AI device will be used to administer single SC dose of tozorakimab on Day 1.
Accessorised Prefilled Syringe (APFS) DeviceDevice
APFS device will be used to administer single SC dose of tozorakimab on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: Tozorakimab (Test) | Experimental | Participants will receive a single SC dose of tozorakimab via AI device. Receives: 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. Receives: Drug: Tozorakimab; Device: Accessorised Prefilled Syringe (APFS) Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From Day 1 to Day 113
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Day 1 to Day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start7 Apr 2025
- Primary completion25 Nov 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908577
- Sponsor's protocol ID
- D9180C00006
- Other IDs
- 2024-511840-22, 2024-511840-22-00
- Status last verified
- Nov 2025
- First submitted
- 2 Apr 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06908577
- Acronym / sponsor ID
- D9180C00006
- Conditions
- Healthy Participants
- Keywords
- Anti-Interleukin (IL)-33 antibody, Human immunoglobulin G1 monoclonal antibody, Accessorised Prefilled Syringe (APFS), Autoinjector (AI), Respiratory and Inflammation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A: Tozorakimab (Test) | Experimental | Drug: Tozorakimab, Device: Autoinjector (AI) DeviceParticipants will receive a single SC dose of tozorakimab via AI device. |
| Treatment B: Tozorakimab (Reference) | Active comparator | Drug: Tozorakimab, Device: Accessorised Prefilled Syringe (APFS) DeviceParticipants will receive a single SC dose of tozorakimab via APFS device with the same container closure as the AI. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TozorakimabAlso: MEDI3506Tozorakimab will be administered as a single SC dose using an AI or APFS device on Day 1. | Drug | Treatment A: Tozorakimab (Test), Treatment B: Tozorakimab (Reference) |
| Autoinjector (AI) DeviceAI device will be used to administer single SC dose of tozorakimab on Day 1. | Device | Treatment A: Tozorakimab (Test) |
| Accessorised Prefilled Syringe (APFS) DeviceAPFS device will be used to administer single SC dose of tozorakimab on Day 1. | Device | Treatment B: Tozorakimab (Reference) |
Primary outcome
Area under concentration-time curve from time 0 to infinity (AUCinf) of tozorakimab
Time frame: 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.
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast) of tozorakimab
Time frame: 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.
Maximum observed drug concentration (Cmax) of tozorakimab
Time frame: 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.
7 secondary outcomes
Time to reach maximum observed concentration (Tmax)
Time frame: From Day 1 to Day 113
Terminal elimination half-life (t1/2λz)
Time frame: From Day 1 to Day 113
Terminal rate constant (λz)
Time frame: From Day 1 to Day 113
Apparent total body clearance (CL/F)
Time frame: From Day 1 to Day 113
Apparent volume of distribution based on the terminal phase (Vz/F)
Time frame: From Day 1 to Day 113
Number of participants with adverse events (AEs)
Time frame: From screening (Day -28 to -2) to follow up (Day 113)
Number of participants with positive anti-drug antibodies (ADA)
Time frame: From Day 1 to Day 113
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tozorakimab, Autoinjector (AI) Device and Accessorised Prefilled Syringe (APFS) Device in people with Healthy Participants, run by AstraZeneca at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under concentration-time curve from time 0 to infinity (AUCinf) of tozorakimab (time frame: From Day 1 to Day 113). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025; AzTrials last refreshed its copy on 6 Nov 2026.