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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01347190

Enrollment

Registered

2011-05-04

Start date

2011-04-30

Completion date

2011-08-31

Last updated

2012-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis

Brief summary

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

Interventions

BIOLOGICALCR002 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.

BIOLOGICALPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Frequency of Adverse events	44 Days (Day -21 to Day 22)

Countries

Bulgaria, Hungary, Poland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026