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

NCT00671736 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2009-08-27

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Moli1901

2,5 ml inhalation solution, 8 weeks treatment period

DRUG

Moli1901 placebo

2,5 ml placebo solution, 8 weeks treatment period

Sponsors & Collaborators

  • AOP Orphan Pharmaceuticals AG

    lead INDUSTRY

Principal Investigators

  • Ernst Eber, Prof Dr · Medical University of Graz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • Austria

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00671736 on ClinicalTrials.gov