A Study to Assess the Tolerability, Safety, and Pharmacokinetics of Subcutaneous Immune Globulin Infusion 10% (Human) With Recombinant Human Hyaluronidase (HYQVIA/HyQvia) With Ramp-up and No Ramp-up Dosing in Healthy Adult Participants
Condition: Healthy Volunteers
Intervention: HYQVIA; HYQVIA; HYQVIA; HYQVIA; HYQVIA; HYQVIA
Intervention description: Participants received a SC infusion of HYQVIA 0.1 g/kg (1/4 of TDL) on Day 1 and 8, 0.2 g/kg (1/2 of TDL) on Day 15, 0.3 g/kg (3/4 of TDL) on Day 29 followed by 0.4 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.; Participants received a SC infusion of HYQVIA 0.25 g/kg (1/4 of TDL) on Day 1 and 8, 0.5 g/kg (1/2 of TDL) on Day 15, 0.75 g/kg (3/4 of TDL) on Day 29 followed by 1.0 g/kg (full TDL) on Day 50 in Ramp-Up dosing manner.; Participants received a SC infusion of HYQVIA 0.2 g/kg (1/2 of TDL) on Day 1 and 15, followed by 0.4 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.; Participants received a SC infusion of HYQVIA 0.5 g/kg (1/2 of TDL) on Day 1 and 15, followed by 1.0 g/kg (full TDL) on Day 29 and 57 in Ramp-Up dosing manner.; Participants received a SC infusion of HYQVIA 0.4 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.; Participants received a SC infusion of HYQVIA 1.0 g/kg (full TDL) SC infusion on Day 1, 29 and 57 without Ramp-Up dosing manner.
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin; Immunoglobulin G
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 19 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to assess the tolerability, safety, and pharmacokinetics of
      HYQVIA with ramp-up and no ramp-up dosing 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 (personally or via a legally
             authorized representative) informed consent 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 females of non-childbearing
             potential

          -  Must be considered "healthy". Healthy as determined by the investigator on the basis
             of screening evaluations and 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 electro cardiogram (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 participant's participations in the trial
             and compromise the trial objectives or any condition that presents undue risk from the
             investigational product or procedures Note: Participants on stable dose of hormone
             replacements (i.e. 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 investigational product(s),
             closely related compounds, or any of the stated ingredients (e.g. human 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

          -  Significant illness, as judged by the investigator, within 30 days of the first dose
             of investigational product

          -  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 investigational product

          -  Participants will be excluded if any of the following laboratory parameters meet the
             criteria below:

          -  Hemoglobin less than (<) 11 gram per deciliter (g/dL). Absolute neutrophil count less
             than or equal to (< or =) 1500/ cubic millimeter (mm^3) and platelet count less than
             or equal to (< or =) 100,000/mm^3 Liver function: alanine aminotransferase (ALT)
             greater than or equal to > or =2.5 × upper limit normal (ULN), aspartate
             aminotransferase (AST) > or =2.5 × upper limit normal (ULN), alkaline phosphatase > or
             =1.5 × ULN or total bilirubin > or =1.5 milligram per deciliter (mg/dL) Renal
             function: creatinine clearance <or= 60 milliliter per minute (mL/min) based on
             Cockcroft-Gault equation Coagulation tests: activated partial thromboplastin time
             (aPTT) >1.2 X ULN; international normalized ratio (INR) >1.2 Participants will be
             excluded if any other laboratory values are outside the reference range and are
             clinically significant per investigator's judgment.

          -  Within 30 days prior to the first dose of investigational product:

               -  Has participated in another clinical study involving immunoglobulin products
                  within 12 months of screening.

               -  Have used an investigational product (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) 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 mmHg or <89 mmHg and diastolic blood pressure
             >89 mmHg or <49 millimeters of Mercury (mmHg)

          -  A positive screen for alcohol or drugs of abuse at screening or 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 CRU

          -  Severe dermatitis or anatomical abnormality that would interfere with HYQVIA
             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 are 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 each
             infusion visit and through 72 hours post last infusion

          -  Current or relevant history of hypercoagulable conditions (e.g. Protein C, Protein S,
             and antithrombin III deficiency), thrombotic/thromboembolic events or venous
             thrombosis