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A study to evaluate the safety and tolerability of a new antimicrobial medicine in people with cystic fibrosis (CF) and non-CF bronchiectasis

Details

Therapeutic category
the type of treatment or therapy being studied. A therapy could range from a medication addressing a particular characteristic of CF to a device or activity e.g. exercise

Anti-Infective

Trial status

Project in Setup

Phase
the different stages involved in the development of a new medication. Phase I focuses on initial safety in people. Phase 2 evaluates safety, correct dose and early signs of whether the medication works. Phase 3 is the stage before medication licensing and looks at safety and medication effectiveness. Phase 4 evaluates longer term use of a medication after it has been licensed for use

Phase I

Full title

Randomized, double-blind, placebo-controlled study of the safety, tolerability and pharmacokinetics after single ascending doses or multiple ascending doses of hypothiocyanite (OSCN-), / bovine Lactoferrin (bLF), or their combination (ALX-009) in healthy male volunteers and patients suffering from cystic fibrosis (CF) and non-CF bronchiectasis (NCFBE).

ALX-009 is composed of hypothiocyanite ion (OSCN-) and lactoferrin, two substances that are naturally occurring components of the immune system in the lungs but are lacking in CF patients’ lungs. It has been demonstrated in vitro that OSCN- and lactoferrin are capable of killing all tested Gram(-) bacteria, including bad bugs resistant to available antibiotics. This clinical trial is split into four parts. People with CF or bronchiectasis are planned to be enrolled in the fourth part, the main purpose of which is to assess the safety of ALX-009 after repeated administration of increasing doses. The doses will be chosen on the basis of the results obtained from the previous parts of the study in healthy volunteers. The study takes place over approximately 5 weeks including one screening visit, a treatment period of 7 consecutive days, twice daily and a final study visit.

Trial Reference Number

111543

Trial type

Medication

Recruitment target
the number of participants who need to be recruited for the trial in the UK

12

Last edited date

28 August 2020

CF sponsor

Alaxia SAS

CF sponsor type

Commercial

Who can take part?

Age

18+

Top inclusion criteria
  • 18 years old +
  • FEV1 more than or equal to 60%
Top exclusion criteria
  • Presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic or infectious disease
  • Frequent headaches and/or migraines, recurrent nausea and/or vomiting