Healthy Participants StudyPhase 1NCT05339100
Accessorized Pre-Filled Syringe to Autoinjector Pharmacokinetic Bridging Study in Anifrolumab
A Phase 1 study testing Anifrolumab, Autoinjector and Accessorized Pre-Filled Syringe in people with Healthy Participants Study, run by AstraZeneca at 3 sites in 3 countries.
Trial summary
This study will be conducted to compare the pharmacokinetic (PK) exposure after a single SC dose of anifrolumab administered using an AI with the PK exposure after a single subcutaneous (SC) dose of anifrolumab administered using APFS in healthy male and female volunteers. 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 Study
- What is being tested?
- Anifrolumab, Autoinjector and Accessorized Pre-Filled Syringe
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 22 Mar 2022to 13 Apr 2023
- 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 male and female participants (childbearing and non-childbearing potential) aged 18 - 55 years (inclusive) at Screening with suitable veins for cannulation or repeated venipuncture at screening.
- Female participants of childbearing potential must have a negative pregnancy test at Screening.
- Female participants of childbearing and non-childbearing potential and male participants must adhere to the contraception methods.
- Have a body mass index between 18.5 and 30 kg/m^2 inclusive and weigh at least 50 kg and no more than 110 kg inclusive at Screening.
- Participants must have immunity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), either by having recovered from a SARS-CoV-2 infection (should have recovered from infection at least 6 weeks before Screening Visit as confirmed by a COVID-19 test) or fully vaccinated against SARS CoV-2 with vaccines approved in the local region (should have received the final vaccine dose at least 2 weeks before Screening Visit).
- Participant should meet all of following tuberculosis (TB) criteria:
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- No signs or symptoms of active TB prior to or during any Screening Visit.
- No medical history or past physical examinations suggestive of active TB.
- No recent contact with a person with active TB OR if there has been such contact, referral to a physician specializing in TB to undergo additional evaluation prior to randomization (documented comprehensively in source), and, if warranted, receipt of appropriate treatment for latent TB at or before the first administration of investigational product.
- No history of latent TB prior to initial Screening visit, with the exception of latent TB with documented completion of appropriate treatment.
- Negative result for an Interferon-gamma (IFN-γ) release assay (IGRA) (eg QuantiFERON-TB Gold [QFT-G] test) test for TB at screening.
Who cannot join
- Lactating or pregnant females or females who intend to become pregnant or begin breastfeeding anytime from initiation of Screening until 1 month after the final Follow-up Visit.
- History or presence of hepatic or renal diseases known to interfere with the PK of anifrolumab.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the administration of study intervention, as judged by the Investigator.
- Any clinically significant abnormalities in in clinical chemistry, hematology, or urinalysis results, at Screening and/or admission to the Clinical Unit.
- Any clinically significant abnormal findings in vital signs at Screening and/or admission to the Clinical Unit.
- Any clinically significant abnormalities on 12-lead electrocardiogram at Screening, as judged by the Investigator.
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- Any positive result on Screening for serum hepatitis B surface antigen OR anti-HBc antibody, hepatitis C antibody, and Human immunodeficiency virus antibody.
- Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of randomization.
- Clinically significant chronic infection (eg, osteomyelitis, bronchiectasis, etc.) within 8 weeks prior to signing the informed consent form (ICF).
- Any infection requiring hospitalization or treatment with IV anti-infective medications not completed at least 4 weeks prior to signing the ICF.
- Any infection requiring oral anti-infective medications (including antivirals) within 2 weeks prior to Day 1.
- History of severe Coronavirus Disease 2019 (COVID-19) infection requiring hospitalization within the last 12 months prior to Screening, or clinical history compatible with Long COVID 19 (symptoms beyond 12 weeks of acute infection), as judged by the Investigator.
- COVID-19 infection before or during Screening and/or admission confirmed by a COVID 19 test (at the London Clinical Unit, participants will have a PCR test on Day -2 only. Additional testing may be performed as required at the discretion of the investigator.
- Known or suspected history of drug abuse, as judged by the Investigator.
- Positive screen for drugs of abuse or cotinine at Screening or on admission to the Clinical Unit or positive screen for alcohol at Screening or on admission to the Clinical Unit.
- Participation in another clinical trial, or has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the administration of SI in this study. The period of exclusion begins 3 months after the final dose or 5 half-lives, whichever is the longest.
- Plasma donation within 1 month of Screening or any blood donation/loss more than 500 mL during the 3 months prior to Screening.
- A known history of allergy or reaction to any component of the IP formulation or history of anaphylaxis to any human gamma globulin therapy.
- Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to Screening.
- Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the administration of SI.
- Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the Investigator. Excessive intake of alcohol defined as the regular consumption of more than 24 g of alcohol per day for men or 12 g of alcohol per day for women (for the London unit: regularly consuming >21 units of alcohol per week for males or >14 units of alcohol per week for females).
- Excessive intake of caffeine-containing drinks or food (eg, coffee, tea, chocolate) as judged by the Investigator. Excessive intake of caffeine defined as the regular consumption of more than 600 mg of caffeine per day (eg, >5 cups of coffee) or would likely be unable to refrain from the use of caffeine-containing beverages during confinement at the investigational site.
- Participants who have previously received anifrolumab.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: A Multicenter, Randomized, Open-label, Parallel Phase 1 Comparability Study of Anifrolumab Administered Using Accessorized Pre-Filled Syringe (APFS) or Autoinjector (AI) in Healthy Volunteers
This study will be conducted to compare the pharmacokinetic (PK) exposure after a single SC dose of anifrolumab administered using an AI with the PK exposure after a single subcutaneous (SC) dose of anifrolumab administered using APFS in healthy male and female volunteers.
Read the detailed description
This will be a multicenter, randomized, open-label, parallel group Phase 1 study.
After meeting the eligibility criteria, all eligible participants will be randomized 1:1:1:1:1:1 to a device group (APFS or AI) for an anatomical injection site as defined in the protocol. Randomization will be stratified by protocol defined body weight categories and clinical unit.
The study will comprise:
- A Screening Period up to 28 days.
- One treatment period during which eligible participants will be admitted to the Clinical Unit on Day -1 to reassess their eligibility. Participants who meet eligibility criteria will be randomized to receive a single subcutaneous (SC) dose of anifrolumab by either APFS or AI device on Day 1. Participants will be discharged on Day 3.
- The participants will return to the center for Follow-up Visits on Days 6, 8, 12, 15, 22, 29, and 43.
- A final Follow-up Visit on Day 57.
- Conditions
- Healthy Participants Study
- Being tested
- Anifrolumab, Autoinjector, Accessorized Pre-Filled Syringe
- Keywords
- Monoclonal Antibody, Anifrolumab, Anifrolumab administered using autoinjector, Anifrolumab administered using accessorized pre-filled syringe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnifrolumabDrug
Participants will receive SC doses anifrolumab via AI or APFS.
AutoinjectorDevice
Autoinjector will be use to administer single SC dose of anifrolumab.
Accessorized Pre-Filled SyringeDevice
Accessorized Pre-filled syringe will be use to administer single SC dose of anifrolumab.
| Study group | Role | What they receive |
|---|---|---|
| Anifrolumab administered using AI | Experimental | Randomized participants will receive a single SC dose of anifrolumab via AI. Receives: Drug: Anifrolumab; Device: Autoinjector |
| Anifrolumab administered using APFS | Active comparator | Randomized participants will receive a single SC dose of anifrolumab via APFS. Receives: Drug: Anifrolumab; Device: Accessorized Pre-Filled Syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under serum concentration-time curve from time zero extrapolated to infinity (AUCinf)
Evaluation of AUCinf following single SC administration of anifrolumab by AI is comparable to the AUCinf following single SC administration of anifrolumab using APFS will be done.
Measured: Up to Day 57
Area under serum concentration-time curve from time zero to last quantifiable concentration (AUClast)
Evaluation of AUClast following single SC administration of anifrolumab by AI is comparable to the AUClast following single SC administration of anifrolumab using APFS will be done.
Measured: Up to Day 57
Maximum observed serum (peak) drug concentration (Cmax)
Evaluation of Cmax following single SC administration of anifrolumab by AI is comparable to the Cmax following single SC administration of anifrolumab using APFS will be done.
Measured: Up to Day 57
Secondary outcomes (8)
Time to reach peak or maximum observed concentration (tmax)
Evaluation of the tmax of anifrolumab administered to various anatomical injection sites and in healthy participants within different body weight ranges.
Measured: Day 1 to Day 57
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz)
Evaluation of the t1/2λz of anifrolumab administered to various anatomical injection sites and in healthy participants within different body weight ranges will be done.
Measured: Day 1 to Day 57
Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRT)
Evaluation of the MRT of anifrolumab administered to various anatomical injection sites and in healthy participants within different body weight ranges will be done.
Measured: Day 1 to Day 57
Apparent total body clearance of drug after extravascular administration (CL/F)
Evaluation of the CL/F of anifrolumab administered to various anatomical injection sites and in healthy participants within different body weight ranges will be done.
Measured: Day 1 to Day 57
Apparent volume of distribution following extravascular administration (based on terminal phase) (Vz/F)
Evaluation of the Vz/F of anifrolumab administered to various anatomical injection sites and in healthy participants within different body weight ranges will be done.
Measured: Day 1 to Day 57
Time of last quantifiable concentration (tlast)
Evaluation of the tlast of anifrolumab administered to various anatomical injection sites and in healthy participants within different body weight ranges will be done.
Measured: Day 1 to Day 57
Number of participants with positive Anti-drug antibodies (ADA)
Evaluation of the immunogenicity of anifrolumab delivered by AI or APFS will be done.
Measured: Day 1, 29 and 57
Number of participants with adverse events and serious adverse events
Evaluation of safety and tolerability of AI- vs APFS-administered anifrolumab will be done.
Measured: Screening period (Day -28 to Day-2) through follow-up visit (Day 57) and evaluation of injection site reaction (Days 1 to 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start22 Mar 2022
- Primary completion13 Apr 2023
- Study completion13 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Participants StudyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 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
- NCT05339100
- Sponsor's protocol ID
- D3465C00002
- Other IDs
- 2021-004896-14
- Status last verified
- May 2023
- First submitted
- 7 Mar 2022
- Last updated
- 11 May 2023
- 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. 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 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-label, Parallel Phase 1 Comparability Study of Anifrolumab Administered Using Accessorized Pre-Filled Syringe (APFS) or Autoinjector (AI) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05339100
- Acronym / sponsor ID
- D3465C00002
- Conditions
- Healthy Participants Study
- Keywords
- Monoclonal Antibody, Anifrolumab, Anifrolumab administered using autoinjector, Anifrolumab administered using accessorized pre-filled syringe
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 13 Apr 2023 (actual)
- Study completion
- 13 Apr 2023 (actual)
- First posted
- 21 Apr 2022 (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.
This study will be conducted to compare the pharmacokinetic (PK) exposure after a single SC dose of anifrolumab administered using an AI with the PK exposure after a single subcutaneous (SC) dose of anifrolumab administered using APFS in healthy male and female volunteers.
Detailed description
This will be a multicenter, randomized, open-label, parallel group Phase 1 study.
After meeting the eligibility criteria, all eligible participants will be randomized 1:1:1:1:1:1 to a device group (APFS or AI) for an anatomical injection site as defined in the protocol. Randomization will be stratified by protocol defined body weight categories and clinical unit.
The study will comprise:
- A Screening Period up to 28 days.
- One treatment period during which eligible participants will be admitted to the Clinical Unit on Day -1 to reassess their eligibility. Participants who meet eligibility criteria will be randomized to receive a single subcutaneous (SC) dose of anifrolumab by either APFS or AI device on Day 1. Participants will be discharged on Day 3.
- The participants will return to the center for Follow-up Visits on Days 6, 8, 12, 15, 22, 29, and 43.
- A final Follow-up Visit on Day 57.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anifrolumab administered using AI | Experimental | Drug: Anifrolumab, Device: AutoinjectorRandomized participants will receive a single SC dose of anifrolumab via AI. |
| Anifrolumab administered using APFS | Active comparator | Drug: Anifrolumab, Device: Accessorized Pre-Filled SyringeRandomized participants will receive a single SC dose of anifrolumab via APFS. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy male and female participants (childbearing and non-childbearing potential) aged 18 - 55 years (inclusive) at Screening with suitable veins for cannulation or repeated venipuncture at screening.
- Female participants of childbearing potential must have a negative pregnancy test at Screening.
- Female participants of childbearing and non-childbearing potential and male participants must adhere to the contraception methods.
- Have a body mass index between 18.5 and 30 kg/m^2 inclusive and weigh at least 50 kg and no more than 110 kg inclusive at Screening.
- Participants must have immunity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), either by having recovered from a SARS-CoV-2 infection (should have recovered from infection at least 6 weeks before Screening Visit as confirmed by a COVID-19 test) or fully vaccinated against SARS CoV-2 with vaccines approved in the local region (should have received the final vaccine dose at least 2 weeks before Screening Visit).
Key exclusion criteria (23 listed)
- Lactating or pregnant females or females who intend to become pregnant or begin breastfeeding anytime from initiation of Screening until 1 month after the final Follow-up Visit.
- History or presence of hepatic or renal diseases known to interfere with the PK of anifrolumab.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the administration of study intervention, as judged by the Investigator.
- Any clinically significant abnormalities in in clinical chemistry, hematology, or urinalysis results, at Screening and/or admission to the Clinical Unit.
- Any clinically significant abnormal findings in vital signs at Screening and/or admission to the Clinical Unit.
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 |
|---|---|---|
| AnifrolumabParticipants will receive SC doses anifrolumab via AI or APFS. | Drug | Anifrolumab administered using AI, Anifrolumab administered using APFS |
| AutoinjectorAutoinjector will be use to administer single SC dose of anifrolumab. | Device | Anifrolumab administered using AI |
| Accessorized Pre-Filled SyringeAccessorized Pre-filled syringe will be use to administer single SC dose of anifrolumab. | Device | Anifrolumab administered using APFS |
Primary outcome
Area under serum concentration-time curve from time zero extrapolated to infinity (AUCinf)
Time frame: Up to Day 57
Evaluation of AUCinf following single SC administration of anifrolumab by AI is comparable to the AUCinf following single SC administration of anifrolumab using APFS will be done.
Area under serum concentration-time curve from time zero to last quantifiable concentration (AUClast)
Time frame: Up to Day 57
Evaluation of AUClast following single SC administration of anifrolumab by AI is comparable to the AUClast following single SC administration of anifrolumab using APFS will be done.
Maximum observed serum (peak) drug concentration (Cmax)
Time frame: Up to Day 57
Evaluation of Cmax following single SC administration of anifrolumab by AI is comparable to the Cmax following single SC administration of anifrolumab using APFS will be done.
8 secondary outcomes
Time to reach peak or maximum observed concentration (tmax)
Time frame: Day 1 to Day 57
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz)
Time frame: Day 1 to Day 57
Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRT)
Time frame: Day 1 to Day 57
Apparent total body clearance of drug after extravascular administration (CL/F)
Time frame: Day 1 to Day 57
Apparent volume of distribution following extravascular administration (based on terminal phase) (Vz/F)
Time frame: Day 1 to Day 57
Time of last quantifiable concentration (tlast)
Time frame: Day 1 to Day 57
Number of participants with positive Anti-drug antibodies (ADA)
Time frame: Day 1, 29 and 57
Number of participants with adverse events and serious adverse events
Time frame: Screening period (Day -28 to Day-2) through follow-up visit (Day 57) and evaluation of injection site reaction (Days 1 to 3)
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 11 May 2023.
- 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. 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.
3 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 Anifrolumab, Autoinjector and Accessorized Pre-Filled Syringe in people with Healthy Participants Study, run by AstraZeneca at 3 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 11 inclusion and 23 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 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 serum concentration-time curve from time zero extrapolated to infinity (AUCinf) (time frame: Up to Day 57). 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 11 May 2023.