A Study of TAK-881 in Healthy Adults
Condition: Healthy Volunteers
Intervention: TAK-881
Intervention description: Participants will receive subcutaneous infusion of TAK-881 on Day 1.
Intervention MeSH terms: Immunoglobulins; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 19 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main aims of this study are to check for side effects from TAK-881 in healthy adults and
      to learn how much TAK-881 they can receive without getting side effects from it.

      During the study, participants will receive one infusion of TAK-881 under the skin
      (subcutaneous infusion) on Day 1 at a lower dose level followed by participants receiving one
      infusion of higher dose levels with ongoing safety monitored by the doctor to ensure optimal
      tolerability and safety.

      Participants will stay in the clinic for 4 days and will come back after 4 weeks. A follow up
      visit will take place 12 weeks after the TAK-881 infusion.
    

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 (personally or via a
             legally-authorized representative) informed consent as applicable to participate in
             the study.

          -  Age 19-50 years 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-breastfeeding female who agrees to comply with any
             applicable contraceptive requirements of the protocol, or female of non-childbearing
             potential.

          -  Must be considered "healthy." Healthy as determined by the investigator on the basis
             of screening evaluations. 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 (BMI) between 18.0 and 30.0 kilogram per square meter (kg/m^2)
             inclusive.

        Exclusion Criteria:

        - Any current or relevant history of medical (e.g., any hematological, hepatic,
        respiratory, cardiovascular, renal, or neurological) or psychiatric conditions, which by
        judgment of the investigator might compromise the safety of the participant or integrity of
        the study, interfere with the participants participation in the trial and compromise the
        trial objectives, or any condition that presents an undue risk from the IP or procedures.

        Note: Participants on stable dose of hormone replacements (e.g., thyroid hormone
        replacement) or oral contraceptives are permitted.

          -  Clinically significant cardiac conditions including but not limited to uncontrolled
             hypertension, myocardial infarction, unstable coronary artery disease and clinically
             significant arrhythmias and conduction disorders.

          -  Known or suspected intolerance or hypersensitivity to the IP(s), closely related
             compounds, or any of the stated ingredients (e.g., human immune globulin (IG),
             hyaluronidase, albumin).

          -  Known history of hypersensitivity or severe allergic reactions (e.g., urticaria,
             breathing difficulty, severe hypotension, or anaphylaxis) following administration of
             blood or blood components.

          -  Known allergy to hyaluronidase of human (including recombinant human hyaluronidase) or
             animal origin (such as bee or wasp venom).

          -  Significant illness, as judged by the investigator, within 30 days of the first dose
             of IP.

          -  Known history of alcohol or other substance abuse within the last year.

          -  Donation of blood within 60 days, or blood products (e.g., plasma or platelets) within
             2 weeks prior receiving the first dose of IP.

          -  Participants will be excluded if abnormal hematology, chemistry, and other laboratory
             values are greater than (>)10% above the upper limit of normal (ULN) or >10% below the
             lower limit of normal (LLN) except for liver function tests and absolute neutrophils.
             Participants will be excluded if any of the following laboratory parameters meet the
             criteria below:

               -  Absolute neutrophil count less than (<) 1.5* 10^9 cells/liter

               -  Liver function: alanine aminotransferase (ALT) greater than or equal to (>=) 1.5*
                  ULN, aspartate aminotransferase (AST) >=1.5* ULN, alkaline phosphatase (ALP)
                  >=1.5* ULN, or total bilirubin >=1.5 milligram per deciliter (mg/dL)

          -  Participants will be excluded if any other laboratory values are outside the reference
             range and are clinically significant per investigator's judgment.

          -  Participants who, within 30 days prior to the first dose of IP:

               -  Have participated in another clinical study involving IG products within 12
                  months of screening.

               -  Have used an IP (or 5 half-lives, whichever is longer).

               -  Have been enrolled in a clinical study (including vaccine studies or has been
                  vaccinated with approved product) that, in the investigator's opinion, may impact
                  this study. Participants who have received any vaccine (including live attenuated
                  vaccines and COVID-19 vaccines) during the last 30 days before dosing will be
                  excluded. No live attenuated virus vaccines are allowed during the study until
                  the end of the follow-up period.

               -  Have had any substantial changes in eating habits, as assessed by the
                  investigator.

          -  Confirmed systolic blood pressure >139 millimeter of mercury (mmHg) or <89 mmHg and
             diastolic blood pressure >89 mmHg or <49 mmHg.

          -  A positive screen for alcohol or drugs of abuse at screening or Day -1 (D-1).

          -  A positive human immunodeficiency virus (HIV), hepatitis C virus (HCV), or
             ongoing/active hepatitis B infection at screening. Participants with immunity to
             hepatitis B from either active vaccination or from previous natural infection are
             eligible to participate in the study.

          -  Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during
             confinement in the clinical research center (CRC).

          -  Severe dermatitis or anatomical abnormality that would interfere with TAK-881
             administration or endpoint assessments. Note: The skin at the administration site
             should not be covered by tattoos.

          -  Current use of any herbal or homeopathic preparations is not permitted.

          -  Unable or unwilling to discontinue antihistamines or medications with antihistamine
             properties, sedatives, anxiolytics, systemic steroids, or topical steroids or
             antibiotics on any area below the chest for a minimum of 48 hours prior to infusion
             visit and through 72 hours post infusion.

          -  Current or relevant history of hypercoagulable conditions (e.g., Protein C, Protein S,
             and antithrombin III deficiency), thrombotic/thromboembolic events or venous
             thrombosis.