Safety and Tolerability Study of Liquid Alpha1 Proteinase Inhibitor (API) in Subjects With Cystic Fibrosis

Study to assess safety and tolerability of a single dose of study-drug administered to Cystic Fibrosis (CF) patients.

Completed

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site 11, Sofia, Bulgaria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Have a confirmed diagnosis of CF: one or more clinical findings consistent with CF and at least one of the following:

Sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test OR
A genotype with two identifiable mutations consistent with CF (∆F508 homozygous or two alleles known to cause a class I, II, or III mutation)
Have an FEV1 ≥30% of predicted normal as defined by age, gender, and height

Exclusion criteria

Oxygen saturation <90%
Changed in treatment regimen within 2 weeks prior to screening
Antibiotics regimen change < 4 weeks before screening
Persistent colonization with Burkholderia cepacia
Serum IgA < 50% of lower level of normal

Treatment and study plan

CR002 Liquid API

Biological

A single nominal dose of CR002 (three different dose groups) will be inhaled as an aerosol mist produced by an I-neb Adaptive Aerosol Delivery (AAD) System.

Placebo

Biological

A single nominal dose of Placebo will be inhaled as an aerosol mist produced by an I-neb Adaptive Aerosol Delivery (AAD) System.

Primary outcomes

Frequency of Adverse events

Time frame: 44 Days (Day -21 to Day 22)

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study title

A Double Blind, Randomized, Placebo Controlled, Single Dose, Phase I Study of the Safety and Tolerability of Alpha1 Proteinase Inhibitor (Human) Inhalation Solution (CR002) in Subjects With Cystic Fibrosis

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: May 4, 2011
Registry last updated: Apr 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed