Safety and Tolerability of MEDI9314 as Single Ascending Dose in Healthy Subjects
Condition: Safety; Healthy Subjects
Intervention: MEDI9314; placebo
Intervention description: single dose of MEDI9314; single dose of placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: MEDI9314; Safety; Tolerability; Pharmacokinetics; Immunogenicity

Summary:

      This is a phase 1a randomized, blinded, placebo-controlled, single-ascending dose study to
      assess the safety and tolerability of MEDI9314 in healthy adult subjects
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written informed consent.

          2. Age 18 through 50 years at the time of screening.

          3. Female subjects must be of non-childbearing potential.

          4. Nonsterilized males who are sexually active with a female partner of childbearing
             potential must use condom and spermicide.

          5. Body mass index of 19.0 through 32.0 kg/m2 at screening.

          6. No clinically significant abnormality on the basis of medical/medication history or
             physical examination.

          7. Negative drugs of abuse (DOA).

          8. Able and willing to comply with the requirements of the protocol and complete the
             study until the end of the safety follow up period.

          9. For the Japanese Cohort, both of the subject's parents and both sets of grandparents
             must be Japanese.

        Exclusion Criteria:

          1. Any condition that, in the opinion of the investigator, would interfere with
             evaluation of the investigational product or interpretation of subject safety or study
             results.

          2. Concurrent enrollment in another clinical study involving any treatment.

          3. Individuals who are legally institutionalized.

          4. Receipt of > 2 marketed or investigational biologic agents.

          5. Receipt of an investigational biologic agent within 4 months or 5 half-lives prior to
             screening, whichever is longer.

          6. Receipt of any investigational non biologic agent within 3 months or 5 half lives
             prior to screening, whichever is longer.

          7. Use of any medication (prescription or over the counter, including herbal remedies)
             within 14 days or 5 half lives of Day 1, whichever is longer, unless in the opinion of
             the investigator and medical monitor the medication will not interfere with the study
             procedures or compromise subject safety.

          8. Known history of allergy or reaction to any component of the investigational product
             formulation.

          9. History of anaphylaxis following any biologic therapy.

         10. Any clinically relevant abnormal findings in physical examination ECG, vital signs,
             and laboratory parameters.

         11. Positive tuberculosis (TB) test (QuantiFERON®-TB Gold In-tube).

         12. Positive hepatitis B surface antigen, hepatitis C virus antibody or HIV test at
             screening.

         13. Receipt of live attenuated vaccines 30 days prior to the date of screening.

         14. Where donation of blood or blood products was in excess of 500 mL within an 8-week
             period in the 3 months prior to screening.