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Dose Escalation Study of ALX-009 in Healthy Men and Cystic Fibrosis (CF) and Non-CF Bronchiectasis Patients

NCT02598999 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2022-02-03

No results posted yet for this study

Summary

This is a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics of a single ascending doses (SAD) and multiple ascending doses (MAD) of Hypothiocyanite (OSCN-), bovine lactoferrin (bLF) and their combination (ALX-009) in healthy male volunteers and patients suffering from cystic fibrosis (CF) and non-CF bronchiectasis (NCFBE).

Conditions

Interventions

DRUG

ALX-009

Solution for inhalation administered through nebulization

DRUG

OSCN-

Solution for inhalation administered through nebulization

DRUG

bLF

Solution for inhalation administered through nebulization

DRUG

Placebo

Solution for inhalation administered through nebulization, Sodium Chloride 0.9%

Sponsors & Collaborators

  • Alaxia SAS

    lead INDUSTRY

Principal Investigators

  • Isabelle Durieu, Prof., MD · Hospices Civils de Lyon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • France

Study Locations

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Entities

Drugs
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 NCT02598999 on ClinicalTrials.gov