GLASSIA Infusion Rate Study



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 65
Updated:2/14/2018
Start Date:July 31, 2012
End Date:January 16, 2013

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A Phase 4 Double-Blind Study to Assess the Safety and Tolerability of Intravenous Administration of GLASSIA in Healthy Adult Volunteers

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.

To achieve proper masking, 30 participants were randomly assigned to receive either GLASSIA
at 0.04 mL/kg/min with a simultaneous administration of placebo (2.5% human albumin in normal
saline) at 0.2 mL/kg/min (Cohort 1) or GLASSIA at 0.2 mL/kg/min with a simultaneous
administration of placebo at 0.04 mL/kg/min (Cohort 2) on Day 1.

Two weeks later (Day 15), the same participants received the second infusion with the
opposite rate of GLASSIA infusion and the corresponding masking placebo infusion.

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
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Overland Park, KS
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