A Study to Assess the Pharmacokinetics and Safety of Single Doses of Anifrolumab in Healthy Subjects

This is a Phase I placebo-controlled study to assess the pharmacokinetics, safety and tolerability of 2 doses of anifrolumab via the subcutaneous (SC) route of administration and 1 dose of anifrolumab via intravenous (IV) route in healthy subjects

Inclusion criteria

• Provision of signed and dated, written informed consent prior to any study specific procedures.
• Healthy male and/or female subjects aged 18 - 55 years.
• Females must have a negative pregnancy test at screening.
• Females with an intact cervix must have documentation of a Pap smear with no documented malignancy.
• Have a body mass index (BMI) between 18 and 32 kg/m2, inclusive, and weigh at least 50 kg.
• Must have adequate abdominal adipose tissue for SC injection.
• No history of latent or active TB prior to screening.
• A chest radiograph with no evidence of current active infection or old active TB, malignancy, or clinically significant abnormalities within 6 months prior to screening.

Exclusion criteria

• History of any clinically significant disease or disorder which may put the subject at risk .
• History or presence of hepatic or renal disease.
• Any clinically significant illness, medical/surgical procedure, or trauma within 8 weeks of participation .
• Any clinically significant chronic or recent infection requiring hospitalization or treatment with anti-infectives.
• History of cancer, apart from squamous or basal cell carcinoma of the skin.
• Any clinically significant lab, vital sign or ECG abnormalities as judged by the investigator.
• Known history of a primary immunodeficiency,HIV splenectomy or an underlying condition.
• Any positive result on screening for hepatitis B, hepatitis C or HIV antibody.
• History of drug abuse within 1 year of participation.
• Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 4 weeks or 5 half-lives prior to participation.
• Previous receipt of:

• Anifrolumab;
• B cell-depleting therapy (including but not limited to epratuzumab, ocrelizumab, or rituximab) ≤ 52 weeks prior to screening.
• History of allergy/hypersensitivity to drugs with a similar chemical structure or class to anifrolumab or to any human gamma globulin therapy.
• Any live or attenuated vaccine within 8 weeks prior to participation.