Study to Evaluate the Safety, Tolerability,Immunogenicity, and Pharmacokinetics of MEDI-528 in Healthy Adult Volunteers
Condition: Asthma
Intervention: MEDI-528 0.3 mg/kg; MEDI-528 1 mg/kg; MEDI-528 3 mg/kg; MEDI-528 9 mg/kg
Intervention description: MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose; MEDI-528 (1 mg/kg) administered as a single, IV dose; MEDI-528 (3 mg/kg) administered as a single, IV dose; MEDI-528 (9 mg/kg) administered as a single, IV dose
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Phase I study to evaluate the safety and tolerability of escalating single IV doses of
      MEDI-528.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females age 18 up to and including 49 years of age at the time of the first
             dose of study drug

          -  Weight < 89 kg

          -  Written informed consent obtained from the volunteer

          -  Healthy by medical history and physical examination

          -  Sexually active females, unless surgically sterile or at least one year
             post-menopausal, must use an effective method of avoiding pregnancy (including oral,
             injectable, transdermal or implanted contraceptives, IUD, female condom, diaphragm
             with spermicide, cervical cap,abstinence, use of a condom by the sexual partner or
             sterile sexual partner) for 3 months before the first dose of study drug, and must
             agree to continue using such precautions through 84 days after their dose of study
             drug. Cessation of birth control after this point should be discussed with a
             responsible physician. Sexually active males, unless surgically sterile, must likewise
             use an effective method of birth control (condom or abstinence) and must agree to
             continue using such precautions through 84 days after their dose of study drug.

          -  Use of common over-the-counter medications such as topical corticosteroids,
             decongestants, antihistamines, analgesics, and antacids is permitted unless, in the
             opinion of the investigator, it would interfere with either the volunteer's ability to
             complete the study or interpretation of study results.

          -  Ability to complete the follow-up period of 84 days

          -  Willing to forego other forms of experimental treatment during the study period of 84
             days

        Exclusion Criteria:

          -  Acute illnesses or evidence of significant active infection, such as fever ≥38.0°C
             (100.5°F) at the start of the study

          -  Use of prescription medications, other than contraceptives, in the 28-day period
             before Study Day 0

          -  Blood donation in excess of 400 mL within 6 months of the time of entry into the study

          -  History of use of tobacco products within 3 years of Study Day 0 or history of smoking
             of >10 pack-years

          -  History of immunodeficiency or receipt or current use of immunosuppressive drugs
             including systemic corticosteroids

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the Study Drug (described in the Investigator's Brochure)

          -  History of substance abuse that, in the opinion of the investigator, may compromise
             the ability of the study subject to complete the study and follow-up period

          -  Evidence of any systemic disease on physical examination

          -  Evidence of infection with hepatitis A, B, or C virus or HIV-1

          -  Receipt of immunoglobulins or blood products within 60 days of entering the study

          -  Receipt of any investigational drug therapy within 60 days of the first dose of study
             drug through Study Day 84 (use of licensed agents for indications not listed in the
             package insert is permitted)

          -  Any of the following: CBC: Hgb < 12.0 gm/dL; WBC < 4,000/mm3; platelet count
             <125,000/mm3 (or laboratory normal values); Na, K, Cl, CO2, AST, ALT, BUN, 4-hour
             fasting glucose, amylase, lipase, creatinine, troponin > upper limit of normal; other
             abnormal laboratory values in the screening panel which in the opinion of the
             principal investigator are judged to be clinically significant.

          -  Clinically significant abnormality, as determined by the investigator, on 12-lead
             electrocardiogram at the time of initial screening

          -  Elective surgery planned during the study period through Study Day 84

          -  Pregnancy (sexually active females must have a negative serum pregnancy test on the
             day of the first dose of the study drug, before dosing)

          -  Nursing mother

          -  The presence of any acute or chronic organ-specific condition or any concern, which in
             the opinion of the investigator, may interfere with the conduct or interpretation of
             the study