Phase 1 Randomized Double-blind Placebo Controlled Study to Evaluate Safety and PK of MEDI3902 in Healthy Adults
Condition: MEDI3902 for Prevention of P. Aeruginosa Pneumonia
MeSH terms: Pneumonia
Intervention: MEDI3902 - Dose 1; MEDI3902 - Dose 2; MEDI3902 - Dose 3; MEDI3902 - Dose 4; Placebo
Intervention description: Participants will receive a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.; Participants will receive a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.; Participants will receive a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.; Participants will received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.; Participants will receive a single dose of placebo by IV infusion up to a maximum of 12 hours.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: MEDI3902; Safety,; Pharmacokinetics,; Healthy Volunteers

Summary:

      This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study
      evaluating the safety and tolerability of a single ascending IV dose of MEDI3902 in healthy
      adult subjects 18 to 60 years of age.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18 through 60 years at the time of screening

          2. Written informed consent

          3. Weight greater than or equal to (>=) 45 kilogram (kg) and less than or equal to (<=)
             110 kg at screening

          4. Healthy by medical history, physical examination, and baseline safety laboratory
             studies

          5. Systolic blood pressure (BP) less than (<) 140 millimeter of mercury (mmHg) and
             diastolic BP < 90 mmHg at screening

          6. Electrocardiogram (ECG) without clinically significant abnormalities at screening

          7. Able to complete the follow-up period through Day 61 as required by the protocol.

          8. Females of childbearing potential who are sexually active with a nonsterilized male
             partner must have used a highly effective method of contraception for at least 28 days
             prior to dosing with investigational product and must agree to continue using such
             precautions through Day 61 of the study.

        Exclusion Criteria:

          1. Acute (time-limited) illness, including fever 99.5 degree Fahrenheit (0^F), on day
             prior to or day of planned dosing

          2. Any drug therapy within 7 days prior to Day 1 (except contraceptives or a single use
             of acetaminophen, aspirin, antihistamine, or combination over-the-counter (OTC)
             product that contains acetaminophen with an antihistamine, or OTC non-steroidal anti
             inflammatory agent at a dose equal to or lower than that recommended on the package).
             Vitamins and other nutritional supplements that are not newly introduced, ie, have
             been taken for at least 30 days prior to enrolment, are not exclusionary

          3. Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 2 months
             prior to screening

          4. Receipt of immunoglobulin or blood products within 6 months prior to screening

          5. Receipt of any investigational product in the preceding 90 days or expected receipt of
             investigational product during the period of study follow-up, or concurrent
             participation in another interventional study Receipt of any vaccine within 7 days
             prior to investigational product dosing or planned receipt within 61 days after
             investigational product dosing except for influenza vaccine administered at least 28
             days after dosing

          6. Previous receipt of a mAb

          7. Immunodeficiency due to illness, including human immunodeficiency virus (HIV)
             infection, or due to drugs, including any course of glucocorticoid therapy exceeding 2
             weeks of prednisone or equivalent at a dose of 20 mg daily or every other day within 6
             months prior to screening. HIV testing must be negative at screening

          8. History of allergic disease or reactions likely to be exacerbated by any component of
             the investigational product

          9. Either history of active infection with hepatitis B or C

         10. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or serum creatinine
             above the upper limit of normal (ULN) or hemoglobin, white blood cell count, or
             platelet count below the lower limit of normal at screening and in the predose blood
             sample

         11. Pregnant or nursing mother

        13. History of alcohol or drug abuse within the past 2 years.