A Study to Assess the Safety of MEDI7836 in Healthy Adults.
Condition: Healthy Adults
Intervention: Placebo SC; MEDI7836 Dose 1; MEDI7836 Dose 2; MEDI7836 Dose 3; MEDI7836 Dose 4
Intervention description: Participants will receive a single-dose of Placebo subcutaneous (SC) injection on Day 1.; Participants will receive a single-dose of MEDI7836 Dose 1 SC injection on Day 1.; Participants will receive a single-dose of MEDI7836 Dose 2 SC injection on Day 1.; Participants will receive a single-dose of MEDI7836 Dose 3 SC injection on Day 1.; Participants will receive a single-dose of MEDI7836 Dose 4 SC injection on Day 1.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To assess the safety of a single ascending dose of MEDI7836 in healthy adult male subjects
      and healthy adult female subjects of non-childbearing potential.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Vital signs, ECG, and laboratory parameters within normal range at screening and Day
             -1

          2. Negative alcohol and drug screen at screening and Day -1

          3. Able and willing to comply with the requirements of the protocol

          4. Females subjects must have been surgically sterilised or be postmenopausal

          5. Nonsterilised males who are sexually active with a female partner of childbearing
             potential or a female partner who has been surgically sterilised by bilateral tubal
             ligation must use a condom with spermicide with their partner from screening until the
             end of the study follow-up period

        Exclusion Criteria:

          1. Concurrent enrolment in another clinical study where the subject is receiving an
             investigational product

          2. Individuals who are legally institutionalised

          3. Receipt of any marketed or investigational biologic agent within 4 months

          4. Receipt of any investigational non-biologic agent within 3 months or 5 half-lives
             prior to screening, whichever is longer

          5. Use of any medication (prescription or over the counter, including herbal remedies)
             within 14 days or 5 half-lives of Day 1,

          6. Known history of allergy or reaction to any component of the investigational product
             formulation

          7. History of anaphylaxis following any biologic therapy

          8. History of chronic alcohol or drug abuse within 12 months prior to screening,

          9. Presence of a positive drug or alcohol screen at screening and Day -1.

         10. Current smoker, or history of smoking within 6 months of screening

         11. Pregnant or breastfeeding women

         12. Any active medical or psychiatric condition or other reason which, in the opinion of
             the investigator or medical monitor, may compromise the safety of the subject in the
             study or interfere with evaluation of the investigational product or reduce the
             subject's ability to participate in the study

         13. Any clinically relevant abnormal findings in physical examination, ECG, vital signs,
             haematology, clinical chemistry or urinalysis during screening or Day -1,

         14. History of any known primary immunodeficiency disorder or use of immunosuppressive
             medication within 12 months of screening

         15. History of a clinically significant infection requiring antibiotics or antiviral
             medication from 30 days prior to screening, up to and including Day 1

         16. Diagnosis of a helminth parasitic infection within 6 months prior to screening that
             has not been treated with, or has failed to respond to, standard of care therapy

         17. History of cancer, except for basal cell carcinoma or in situ carcinoma of the cervix
             treated with apparent success with curative therapy ≥ 12 months prior to screening or
             other malignancies treated with apparent success with curative therapy ≥ 5 years prior
             to screening

         18. Positive tuberculosis (TB) test (Quantiferon-TB Gold) at screening or TB requiring
             treatment within the 12 months prior to the screening visit

         19. Positive hepatitis B surface antigen, hepatitis B anti-core antibody, or hepatitis C
             virus antibody serology at screening.

         20. Subjects with a history of hepatitis B vaccination without history of hepatitis B are
             allowed to enter the study.

         21. A positive human immunodeficiency virus test at screening or subject taking
             antiretroviral medications, as determined by medical history and/or subject's verbal
             report

         22. Evidence of active liver disease, including jaundice or aspartate transaminase (AST),
             alanine transaminase (ALT), or alkaline phosphatase greater than twice the upper limit
             of normal (ULN)

         23. Major surgery within 8 weeks prior to screening, or planed in-patient surgery or
             hospitalisation during the study period

         24. Receipt of live attenuated vaccines 30 days prior to the date of screening Where
             participation in the study would result in donation of blood or blood products in
             excess of 500 mL within an 8-week period