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

A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults With Cystic Fibrosis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00671736

Enrollment

160

Registered

2008-05-05

Start date

2007-10-31

Completion date

2009-07-31

Last updated

2009-08-27

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, Moli1901, Lancovutide, 2622U90, duramycin, lung

Brief 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.

Detailed description

Study Moli1901-010B is a multi center, parallel group, placebo controlled, double-blind efficacy and safety evaluation of three different dosage schedules of aerosolized Moli1901 in adolescents (12 years of age or older), and adults. Study will start with a screening period (visit 1) followed by an 8 weeks double blind comparative treatment period (visit 2-7). Thereafter, subjects will be observed for additional 4 weeks without treatment (follow-up period and visit 8). Spirometry, pulse oximetry and other safety measurements will be performed up to 120 min after study medication inhalation. The study will be conducted in 30 sites in 9 European countries.

Interventions

DRUGMoli1901

2,5 ml inhalation solution, 8 weeks treatment period

DRUGMoli1901 placebo

2,5 ml placebo solution, 8 weeks treatment period

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The change in the percentage of the predicted FEV1 (forced expiratory volume in first second) value	at every study visit

Secondary

Measure	Time frame
The ensemble of two subject reported clinical scores, which are physical dimensions of the self-report, disease-specific quality of life test, the cystic fibrosis questionnaire in the revised version	every 2 weeks

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026