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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-08-31

Brief Summary

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

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Liquid API

Group Type EXPERIMENTAL

CR002 Liquid API

Intervention Type 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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

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

Interventions

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CR002 Liquid API

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.

Intervention Type BIOLOGICAL

Placebo

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

1. Sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test OR
2. 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No