A Study to Determine the Safety, Tolerability, and Pharmacokinetics of Lanadelumab Administered Intravenously in Healthy Adult Volunteer Participants
Condition: Healthy Volunteers
Intervention: Lanadelumab; Placebo
Intervention description: Participants will receive lanadelumab 300 mg IV infusion on Day 1 followed by Day 4.; Participants will receive placebo matching to lanadelumab IV infusion on Day 1 followed by Day 4.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 19 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study to evaluate the safety, tolerability and pharmacokinetics (PK) of
      lanadelumab administered by Intravenous (IV) infusion in healthy adult volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, adult, male or female, 19-55 years of age, inclusive, at screening.

          -  Continuous non-smoker who has not used nicotine-containing products for at least 30
             days prior to the first dosing and throughout the study, based on participant
             self-reporting.

          -  Body mass index (BMI) greater than or equal to (>=) 18.0 and less than or equal to
             (<=) 32.0 kilogram per square meter (kg/m^2) at screening.

          -  Medically healthy with no clinically significant medical history, physical
             examination, laboratory profiles, vital signs or electrocardiograms (ECGs), per the
             investigator.

          -  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.

          -  Understands the study procedures in the informed consent form (ICF) and be willing and
             able to comply with the protocol.

        Exclusion Criteria:

          -  Is mentally or legally incapacitated or has significant emotional problems at the time
             of the screening visit or expected during the conduct of the study.

          -  History or presence of clinically significant medical or psychiatric condition or
             disease per the investigator.

          -  History of any illness that might confound the results of the study or poses an
             additional risk to the participant by their participation in the study, per the
             investigator.

          -  History or presence of alcoholism or drug abuse within the past 2 years prior to the
             first dosing per the investigator.

          -  History or presence of hypersensitivity or idiosyncratic reaction to the study drug(s)
             or related compounds.

          -  History or presence 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 clinically significant clinical or laboratory assessments
             per the investigator.

          -  Female participants with a positive pregnancy test or lactating.

          -  Positive urine drug or alcohol results at screening.

          -  Positive results at screening for human immunodeficiency virus (HIV), hepatitis B
             surface antigen (HBsAg) or hepatitis C virus (HCV).

          -  Supine blood pressure is less than 90/40 millimetre of mercury (mmHg) or greater than
             140/90 mmHg at screening.

          -  Supine heart rate is lower than 40 beats per minute (bpm) or higher than 99 bpm at
             screening.

          -  Orthostatic vital sign results with a decrease in systolic greater than (>) 20 mmHg or
             decrease in diastolic > 10 mmHg and increase in pulse of > 20 beats per minute.

          -  QTcF interval is > 450 milliseconds (msec) (males) or > 470 msec (females) or ECG
             findings are deemed abnormal with clinical significance at screening per the
             investigator.

          -  Estimated creatinine clearance less than (<) 80 milliliters per minute (mL/min) at
             screening.

          -  Unable to refrain from or anticipates the use of any drug, including prescription and
             non-prescription medications, herbal remedies, or vitamin supplements within 14 days
             prior to the first dosing and throughout the study. Medication listed as part of
             acceptable birth control methods will be allowed. Thyroid hormone replacement
             medication may be permitted if the participant has been on the same stable dose for
             the immediate 3 months prior to first study drug administration. After
             randomization/dosing, a nonsteroidal anti-inflammatory drug may be administered at the
             discretion of the investigator. Hormone replacement therapy will also be allowed if
             the participant has been on the same stable dose for the immediate 3 months prior to
             first study drug administration.

          -  Has been on a diet incompatible with the on-study diet, per the investigator, within
             the 30 days prior to the first dosing and throughout the study.

          -  Donation of blood or significant blood loss within 56 days prior to the first dosing.

          -  Plasma donation within 7 days prior to the first dosing.

          -  Participation in another clinical study within 30 days or 5 half-lives prior to the
             first dosing. The 30-day window or 5 half-lives will be derived from the date of the
             last blood collection or dosing, whichever is later, in the previous study to Day 1 of
             the current study