A Study to Assess the Pharmacokinetics and Safety of Single Doses of Anifrolumab in Healthy Subjects
Condition: Safety; Pharmacokinetics; Healthy Subjects
Intervention: Anifrolumab SC injection (300mg); Anifrolumab IV infusion (300mg); Anifrolumab SC infusion (600mg); Anifrolumab placebo SC injection (300mg); Anifrolumab placebo IV infusion (300mg); Anifrolumab placebo SC infusion (600mg)
Intervention description: 300 mg of anifrolumab delivered as 2 separate 1 mL SC injections administered serially on Day 1; 300 mg of anifrolumab delivered as an IV infusion over 30 minutes on Day 1; 600 mg of anifrolumab delivered as 4 mL SC by infusion pump on Day 1; 300mg of placebo delivered as 2 separate 1 mL SC injections administered serially on Day 1; 600mg of placebo delivered as an IV infusion over 30 minutes on Day 1; 600 mg of placebo delivered as 4 mL SC by infusion pump on Day 1
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tolerability; Anifrolumab; Subcutaneous injection; Intravenous infusion

Summary:

      This is a Phase I, Randomized, Placebo-Controlled, Double-Blind Study to Assess the
      Pharmacokinetics and Safety of anifrolumab following Single-Dose administration to healthy
      subjects
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provision of signed and dated, written informed consent prior to any study specific
             procedures.

          2. Healthy male and/or female subjects aged 18 - 55 years.

          3. Females must have a negative pregnancy test at screening.

          4. Females with an intact cervix must have documentation of a Pap smear with no
             documented malignancy.

          5. Have a body mass index (BMI) between 18 and 32 kg/m2, inclusive, and weigh at least 50
             kg.

          6. Must have adequate abdominal adipose tissue for SC injection.

          7. No history of latent or active TB prior to screening.

          8. 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:

          1. History of any clinically significant disease or disorder which may put the subject at
             risk .

          2. History or presence of hepatic or renal disease.

          3. Any clinically significant illness, medical/surgical procedure, or trauma within 8
             weeks of participation .

          4. Any clinically significant chronic or recent infection requiring hospitalization or
             treatment with anti-infectives.

          5. History of cancer, apart from squamous or basal cell carcinoma of the skin.

          6. Any clinically significant lab, vital sign or ECG abnormalities as judged by the
             investigator.

          7. Known history of a primary immunodeficiency,HIV splenectomy or an underlying
             condition.

          8. Any positive result on screening for hepatitis B, hepatitis C or HIV antibody.

          9. History of drug abuse within 1 year of participation.

         10. 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.

         11. Previous receipt of:

               -  Anifrolumab;

               -  B cell-depleting therapy (including but not limited to epratuzumab, ocrelizumab,
                  or rituximab) ≤ 52 weeks prior to screening.

         12. History of allergy/hypersensitivity to drugs with a similar chemical structure or
             class to anifrolumab or to any human gamma globulin therapy.

         13. Any live or attenuated vaccine within 8 weeks prior to participation.