GLASSIA Infusion Rate Study
Condition: Alpha1-antitrypsin Deficiency; Healthy Volunteers
MeSH terms: Alpha 1-Antitrypsin Deficiency
Intervention: Alpha1-proteinase inhibitor; Placebo: Human albumin 2.5%
Intervention description: GLASSIA will be supplied as a sterile, non-pyrogenic, ready-to-use solution, in single dose 50 mL vials; for intravenous administration.; Intravenous administration
Intervention MeSH terms: Protease Inhibitors; Alpha 1-Antitrypsin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: for this study; volunteers; Focus; Condition:

Summary:

      The purpose of this study was to generate sufficient safety and tolerability information in
      support of an increase in the infusion rate of intravenous GLASSIA in the prescribing
      information from 0.04 to 0.2 mL/kg/min.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 18 to 65 years of age inclusive, at the time of screening

          -  Body mass index (BMI) in the range of 19.0 to 32.0 kg/m2 (inclusive) and body weight
             >= 50 kg at the time of screening

          -  Healthy subject with no clinical evidence of acute and/or chronic disease and no
             clinically significant abnormalities on hematology panel, clinical chemistry panel,
             urinalysis, or electrocardiogram (ECG) at the time of screening

          -  Negative drug screen test at screening. Subject must agree to refrain from heavy
             alcohol consumption (defined as more than 2 drinks per day on a regular basis) and use
             of narcotic drugs or illegal substances for at least 2 weeks prior to screening and
             throughout the course of the study. Subject must also agree to drug screen testing at
             the discretion of the investigator at any time during the course of the study.

          -  If female of childbearing potential, subject presents with a negative serum pregnancy
             test and agrees to employ adequate birth control measures for the duration of the
             study

          -  If male, the subject must agree to use an acceptable form of birth control throughout
             the study and for at least 90 days after dosing. Additionally, the subject must agree
             to abstain from sperm donation for 90 days after the last administration of
             investigational product.

          -  Subject is willing and able to comply with the requirements of the protocol

        Exclusion Criteria:

          -  Known history of OR positive serological evidence at the time of screening for
             hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), Parvovirus
             B19 (PVB19) or human immunodeficiency virus (HIV) type 1/2 infection

          -  Known history of hypersensitivity or adverse reactions (e.g. urticaria, breathing
             difficulty, severe hypotension, or anaphylaxis) following administration of blood or
             blood components

          -  Documented immunoglobulin A (IgA) deficiency (<7 mg/dL at screening)

          -  Evidence of uncontrolled hypertension (systolic blood pressure of >160 mm Hg, and/or
             diastolic blood pressure of >100 mm Hg despite anti-hypertensive medications)

          -  Subject is nursing or intends to begin nursing during the course of the study

          -  Subject has participated in a clinical trial and has received an investigational
             product within 60 days prior to screening

          -  Subject has a planned medical procedure within the study period

          -  Any clinically significant medical, psychiatric, or cognitive illness or recreational
             drug/alcohol use that, in the opinion of the investigator, may impede the subject's
             ability to comply with the study procedures, pose increased risk to the subject's
             safety, or confound the interpretation of study results