A Study to Determine the Bioavailability of Lanadelumab (SHP643) Administered Subcutaneously With the Prefilled Syringe and the Autoinjector in Healthy Adult Volunteer Participants.
Condition: Healthy Volunteers
Intervention: SHP643
Intervention description: Participants will receive injection of SHP643.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 190.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate bioavailability of lanadelumab (SHP643) following a
      single, 2 milliliter (mL) subcutaneous (SC) dose of 300 milligrams (mg) delivered by
      prefilled syringe (PFS) or auto injector (AI) in healthy adult participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  An understanding, ability, and willingness to fully comply with study procedures and
             restrictions.

          -  Ability to voluntarily provide written, signed, and dated informed consent to
             participate in the study.

          -  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.

          -  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.

          -  Must be considered "healthy", per the investigator. Healthy status is defined by
             absence of evidence of any active or chronic disease following a detailed medical and
             surgical history, a complete physical examination including vital signs, 12-lead
             electrocardiogram (ECG), hematology, blood chemistry, and urinalysis.

          -  Body mass index between 18.5-33 kilogram per square meter (kg/m^2), inclusive, with a
             body weight greater than or equal to (>=) 45 kilogram (kg) (99 pounds [lbs]). This
             inclusion criterion will only be assessed at the screening visit and on Day -1.

          -  Willing and able to consume standardized meals during the confinement period of the
             study.

          -  All participants will be required to consume the identical meals on study days when
             serial PK blood samples are collected

        Exclusion Criteria:

          -  Per the investigator, a 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.

          -  Per the investigator, a current or relevant history of physical or psychiatric
             illness, any medical disorder that may require treatment or make the participant
             unlikely to complete the study, or any condition that present's undue risk from the
             investigational product or procedures.

          -  Known or suspected intolerance or hypersensitivity to the investigational product,
             closelyrelated 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 (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 <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) >139 millimeters of mercury (mmHg) or <89 mmHg,
             and diastolic BP >89 mmHg or <49 mmHg.

          -  Twelve-lead ECG values demonstrating QTcF >450 milliseconds (msec) (males) or >470
             msec (females) at the screening visit or Day -1. If QTcF exceeds 450 msec (males) or
             470 msec (females), the ECG should be repeated 2 more times and the average of the 3
             QTcF values should be used to determine the participants eligibility.

          -  Positive screen for drugs of abuse and/or disallowed drugs (i.e. amphetamines,
             benzodiazepines, barbiturates, cocaine, opiates, phencyclidine) at screening, or drugs
             of abuse or alcohol on Day -1. This screen will include marijuana.

          -  Male participants who consume more than 21 units of alcohol per week or 3 units per
             day. Female participants who consume more than 14 units of alcohol per week or 2 units
             per day. One alcohol unit=1 beer or 1 wine (5 ounces [oz) per 150 milliliter [mL]) or
             1 liquor (1.5 oz/40 mL) or 0.75 oz alcohol.

          -  Positive human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or
             hepatitis C virus (HCV) antibody screen.

          -  Use of tobacco in any form (e.g. smoking or chewing) or other nicotine-containing
             products in any form (e.g. 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 participants who
             experience caffeine withdrawal headaches. One caffeine unit is contained in the
             following items: one 6 oz (180 ml) cup of coffee, two 12 oz (360 ml) cans of cola, one
             12 oz cup of tea, and three 1 oz (85 g) 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 stable hormonal replacement therapy or hormonal
             contraceptives). Current use is defined as use within 14 days of the dose of
             investigational product. (Prior and Concomitant Treatment) for a list of permitted
             medications.

          -  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.