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

PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

April 30, 2011

Primary Completion Date

August 31, 2011

Study Completion Date

August 31, 2011

Conditions
Cystic Fibrosis
Interventions
BIOLOGICAL

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.

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.

Trial Locations (11)

Unknown

Site 11, Sofia

Site 12, Varna

Site 30, Debrecen

Site 24, Bialystok

Site 22, Gdansk

Site 21, Poznan

Site 20, Rabka-Zdrój

Site 23, Warsaw

Site 42, Papworth Hospital

Site 40, Penarth

Site 41, Southampton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

CSL Behring

INDUSTRY