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

Exclusion Criteria

• - 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.
• - 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.