Lancovutide (Moli1901) Inhalation Solution Study in Adolescents and Adults With Cystic Fibrosis

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a dose-finding study for the investigational product Lancovutide (Moli1901) in the exploratory phase IIb to establish minimum effective dose, optimal dose, and maximum safe dose. Additionally, the tolerability of Moli1901 shall be investigated.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AOP Orphan Pharmaceuticals AG

Criteria

Inclusion Criteria:

• Body mass index

• Confirmed diagnosis of cystic fibrosis

• FEV1 between 50% and 85% of predicted

• Oxygen saturation level measured by pulse oximetry (SpO2) >90 % on room air

Exclusion Criteria:

• Bronchial hyperresponsiveness

• Unstable lung function

• Pulmonary disease such as pneumonia, tuberculosis, or lung cancer

• Acute upper respiratory tract infection within the last 2 weeks

• Acute lower respiratory tract infection (requiring antibiotics or hospitalization) within the last 4 weeks

• Pulmonary exacerbation within the last 4 weeks

• Changes from routine maintenance therapy within the last 4 weeks

• Scheduled changes to inhaled antibiotics regimen during the course of the study

• Receive or are planned to receive any treatment via "on-off" regimen (e.g. Tobramycin
• TOBI®); last dose of any "on-off" treatment within the last 6 weeks

• Any clinically significant liver, renal, cardiac, neurological, or hematological disease

• ABPA or colonization with Burkholderia cepacia

• Poorly controlled diabetes mellitus