Accessorized Pre-Filled Syringe to Autoinjector Pharmacokinetic Bridging Study in Anifrolumab

NCT05339100 | Completed Phase 1 FDA Drug

• 2 other identifiers: D3465C000022021-004896-14
• Study Type: interventional
• Target: 180
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Healthy Participants Study

Keywords

Monoclonal Antibody; Anifrolumab; Anifrolumab administered using autoinjector; Anifrolumab administered using accessorized pre-filled syringe

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Up to Day 57

Secondary Outcomes (8)

• Time to reach peak or maximum observed concentration (tmax)

  Day 1 to Day 57

• Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz)

  Day 1 to Day 57

• Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRT)

  Day 1 to Day 57

• Apparent total body clearance of drug after extravascular administration (CL/F)

  Day 1 to Day 57

• Apparent volume of distribution following extravascular administration (based on terminal phase) (Vz/F)

  Day 1 to Day 57

Study Arms (2)

Anifrolumab administered using AI

EXPERIMENTAL

Randomized participants will receive a single SC dose of anifrolumab via AI.

Drug: Anifrolumab; Device: Autoinjector

Anifrolumab administered using APFS

ACTIVE COMPARATOR

Randomized participants will receive a single SC dose of anifrolumab via APFS.

Drug: Anifrolumab; Device: Accessorized Pre-Filled Syringe

Interventions

Anifrolumab DRUG

Participants will receive SC doses anifrolumab via AI or APFS.

Anifrolumab administered using AI; Anifrolumab administered using APFS

Autoinjector DEVICE

Autoinjector will be use to administer single SC dose of anifrolumab.

Anifrolumab administered using AI

Accessorized Pre-Filled Syringe DEVICE

Accessorized Pre-filled syringe will be use to administer single SC dose of anifrolumab.

Anifrolumab administered using APFS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (3)

Research Site

Brooklyn, Maryland, 21225, United States

Location

Research Site

Berlin, 14050, Germany

Location

Research Site

Harrow, HA1 3UJ, United Kingdom

Location

MeSH Terms

Interventions

anifrolumab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: April 21, 2022
• Study Start: March 22, 2022
• Primary Completion: April 13, 2023
• Study Completion: April 13, 2023
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patientlevel data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at: https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.

Locations

GB (1); US (1); DE (1)