GLASSIA Infusion Rate Study

Baxalta

Status and phase: Completed; Phase 4

Conditions: Healthy Volunteers; Alpha1-antitrypsin Deficiency

Treatments: Biological: Alpha1-proteinase inhibitor; Biological: Placebo: Human albumin 2.5%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01651351

471201

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Cohort 1

Experimental group

Description:

Day 1: * GLASSIA at 0.04 mL/kg/min * Placebo at 0.2 mL/kg/min Day 15: * GLASSIA at 0.2 mL/kg/min * Placebo at 0.04 mL/kg/min

Treatment:

Biological: Placebo: Human albumin 2.5%

Biological: Alpha1-proteinase inhibitor

Cohort 2

Experimental group

Description:

Day 1: * GLASSIA at 0.2 mL/kg/min * Placebo at 0.04 mL/kg/min Day 15: * GLASSIA at 0.04 mL/kg/min * Placebo at 0.2 mL/kg/min

Treatment:

Biological: Placebo: Human albumin 2.5%

Biological: Alpha1-proteinase inhibitor