Study of Lanadelumab in Healthy Japanese and Matched Caucasian Adult Subjects
Condition: Healthy Volunteers
Intervention: Lanadelumab
Intervention description: SC injection of 300mg in 2mL (150 mg/mL) solution of lanadelumab will be administered as a single dose injection in the abdomen.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Lanadelumab

Summary:

      The purpose of this study is to evaluate the pharmacokinetics (PK), safety and tolerability
      and pharmacodynamics (PD) of lanadelumab in healthy adult Japanese subjects and matched
      non-Hispanic healthy adult Caucasian subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to voluntarily provide written, signed, and dated informed consent as
             applicable to participate in the study.

          -  An understanding, ability, and willingness to fully comply with study procedures and
             restrictions.

          -  Age 18-55, inclusive, at the time of consent. The date of signature of the informed
             consent is defined as the beginning of the Screening Period. This inclusion criterion
             will only be assessed at the first screening visit.

          -  Subjects must be either:

               1. A subject of Japanese descent born in Japan, who has resided outside of Japan for
                  no longer than 5 years and is of Japanese parentage, defined as having 2 Japanese
                  parents and 4 Japanese grandparents, all born in Japan.

               2. A non-Hispanic, Caucasian subject who has 2 non-Hispanic, Caucasian parents and 4
                  non-Hispanic, Caucasian grandparents.

          -  Male or non-pregnant, non-lactating female who agrees to comply with any applicable
             contraceptive requirements of the protocol or females of non-childbearing potential.

          -  Considered "healthy" by the investigator. Healthy status is defined by absence of
             evidence of any active or chronic disease following a detailed medical and surgical
             history, as well as a complete physical examination including vital signs, 12-lead
             ECG, hematology, blood chemistry, and urinalysis.

          -  Body mass index between 18.5-33 kilograms per square meter (kg/m^2), inclusive, with a
             body weight greater than or equal to (≥) 45 kg (99 pounds [lbs]). This inclusion
             criterion will only be assessed at the screening visit.

          -  Willing and able to consume standardized meals during the confinement period of the
             study. All subjects will be required to consume the identical meals on study days when
             serial PK and PD blood samples are collected.

        Exclusion Criteria:

          -  History of any hematological, hepatic, respiratory, cardiovascular, renal,
             neurological or psychiatric disease, gall bladder removal, or current or recurrent
             disease that could affect the action, absorption, or disposition of the
             investigational product, or clinical or laboratory assessments.

          -  Current or relevant history of physical or psychiatric illness, any medical disorder
             that may require treatment or make the subject unlikely to complete the study, or any
             condition that presents undue risk from the investigational product or procedures.

          -  Known or suspected intolerance or hypersensitivity to the investigational product,
             closely related compounds, or any of the stated ingredients.

          -  Significant illness, as judged by the investigator, within 2 weeks of the dose of
             investigational product.

          -  Known history of alcohol or other substance abuse within the last year, per the
             investigator.

          -  Donation of blood or blood products (example [e.g], plasma or platelets) within 60
             days prior to receiving the dose of investigational product.

          -  Within 30 days prior to the dose of investigational product:

               1. Have used an investigational product (if elimination half-life is less than [<] 6
                  days, otherwise 5 half-lives).

               2. Have been enrolled in a clinical study (including vaccine studies) that, in the
                  investigator's opinion, may impact this Shire-sponsored study.

          -  Confirmed systolic blood pressure (BP) greater than (>) 139 millimeter of mercury
             (mmHg) or <89mmHg, and diastolic BP >89mmHg or <49mmHg.

          -  Twelve-lead ECG values (average of triplicate readings) demonstrating QTc >450
             milliseconds (msec) (males) or >470msec (females) at the Screening Visit or Day -1.

          -  Positive screen for drugs of abuse (that is, amphetamines, benzodiazepines,
             barbiturates, cocaine, marijuana, opiates, phencyclidine) at Screening, or drugs of
             abuse or alcohol on Day -1.

          -  Male subjects who consume more than 21 units of alcohol per week or 3 units per day.
             Female subjects who consume more than 14 units of alcohol per week or 2 units per day.
             One alcohol unit=1 beer or 1 wine (5 ounce [oz]/150 milliliter [mL]) or 1 liquor
             (1.5oz/40mL) or 0.75oz alcohol.

          -  Positive human immunodeficiency virus (HIV), hepatitis B virus surface antigen
             (HBsAg), or hepatitis C virus.(HCV) antibody screen.

          -  Use of tobacco in any form (eg, smoking or chewing) or other nicotine-containing
             products in any form (eg, gum, patch, electronic). Ex-users must report that they have
             stopped using tobacco for at least 30 days prior to receiving the dose of
             investigational product.

          -  Routine consumption of more than 2 units of caffeine per day or subjects who
             experience caffeine withdrawal headaches. One caffeine unit is contained in the
             following items: one 6oz (180mL) cup of coffee, two 12oz (360mL) cans of cola, one
             12oz cup of tea, and three 1oz (85g) chocolate bars. Decaffeinated coffee, tea, or
             cola are not considered to contain caffeine.

          -  Current use of any medication (including over-the-counter, herbal, or homeopathic
             preparations; with the exception of hormonal replacement therapy or hormonal
             contraceptives). Current use is defined as use within 14 days of the dose of
             investigational product.

          -  Abnormal laboratory values considered clinically significant, as determined by the
             investigator at Screening or Day -1.

          -  History of any clinically significant surgery or procedure within 8 weeks of receiving
             the dose of investigational product, as determined by the investigator.