Obstructive Lung Diseases |

Safety and Tolerability of an Intravenously-administered Alpha1-Proteinase Inhibitor (A1PI) at an Increased Infusion Rate: A Randomized, Placebo-Controlled, Phase 4 Study in Healthy Adults FREE TO VIEW

Adam Haeberle, PhD; Leock Ngo, PhD; Niel Inhaber, MD; David Gelmont, MD; Leman Yel, MD
Author and Funding Information

Baxter BioScience, Westlake Village, CA

Chest. 2013;144(4_MeetingAbstracts):712A. doi:10.1378/chest.1689245
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SESSION TITLE: COPD Safety of Treatment Posters

SESSION TYPE: Poster Presentations

PRESENTED ON: Wednesday, October 30, 2013 at 01:30 PM - 02:30 PM

PURPOSE: A1PI (GLASSIA; Kamada Ltd) is indicated for chronic augmentation and maintenance therapy in adults with emphysema due to congenital deficiency of alpha1-proteinase inhibitor, at an intravenous (IV) infusion rate of 0.04 mL/kg/min. This study assessed the safety and tolerability of IV A1PI when administered IV at a faster rate (0.2 mL/kg/min).

METHODS: This is a prospective, randomized, double-blind, active-controlled, crossover study in healthy subjects aged 18-65 years. Day 1: subjects received IV A1PI 0.04 mg/kg/min + placebo 0.2 mg/kg/min [A1PI/0.04] (Cohort 1) or A1PI 0.2 mg/kg/min + placebo 0.04 mg/kg/min [A1PI/0.2] (Cohort 2) simultaneously through a Y-connector into a single infusion site. Day 15: treatments were switched in the same subjects. Safety, tolerability and infusion changes were assessed on Days 1 and 15 and subject diaries (adverse events [AEs]; concomitant medications) were collected on Day 29. Laboratory assessments were performed at Screening and on Days 1, 15, 29 and 105. Safety outcomes included evaluation of infusion rate reductions and discontinuations due to related AEs; infusions with temporally associated AEs; treatment-related AEs; and a positive test (serology/nucleic acid) for blood-borne viruses.

RESULTS: Thirty subjects were randomized (15/each cohort) and completed the study through Day 105. The mean age was 28 years (range 19-61), 77% were male, and mean BMI was 25.3 kg/m2 (range 19.5-31.5). No serious AEs or severe/moderate AEs were reported. Mild AEs were reported in 43.3% (A1PI/0.04) and 26.7% (A1PI/0.2) of subjects. Related AEs occurred in 13.3% (A1PI/0.04) and 6.7% (A1PI/0.2) of subjects. No virology results were positive following dosing. There were no reductions in infusion rate, and no infusion interruptions or discontinuations due to AE.

CONCLUSIONS: IV A1PI was safe and well tolerated at infusion rates of 0.2 mL/kg/min when administered to healthy subjects.

CLINICAL IMPLICATIONS: Compared with an infusion rate of IV A1PI at 0.04 mg/kg/min, the rate of 0.2 mg/kg/min is not associated with an increase in AEs, supporting faster A1PI administration and a decreased infusion duration.

DISCLOSURE: Adam Haeberle: Employee: Employee of Baxter BioScience Leock Ngo: Employee: Employee of Baxter BioScience Niel Inhaber: Employee: Former employee of Baxter BioScience David Gelmont: Employee: Employee of Baxter BioScience Leman Yel: Employee: Employee of Baxter BioScience

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