Phase 1 Three Part SAD, MAD & Cross-Over Study of ZP-059
Research type
Research Study
Full title
A Phase 1, Three-Part, Open-Label Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Doses of Inhaled Voriconazole (ZP-059) in Healthy Subjects (Part 1), Multiple Doses of ZP-059 in Mild Stable Asthma Subjects (Part 2) and in a Two-Period Crossover Study of Single Doses of ZP-059 and Single Doses of Oral Voriconazole in Mild to Moderate Stable Asthma Subjects (Part 3)
IRAS ID
273794
Contact name
Arnd Mueller
Contact email
Sponsor organisation
Zambon S.p.A
Eudract number
2019-004031-23
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 10 days
Research summary
The study drug, ZP-059, is an approved antifungal drug being investigated as in a potential new inhaled formulation for the treatment of allergic bronchopulmonary aspergillosis (ABPA).
The immune system of people with ABPA typically have an exaggerted (overly sensitive) response within the body, when exposed to Aspergillus moulds (fungus). This response can cause damage to the lungs. Unfortunately, being exposed to Aspergillus is unavoidable as it can be found everywhere. ABPA occurs most often in patients with lung diseases such as asthma or cystic fibrosis. Symptoms of ABPA include fever, a cough that may bring up blood or thick mucus, worsening asthma or shortness of breath.
Voriconazole (the active ingredient in ZP-059) has been given to people before and is currently prescribed in the form of tablets or liquids that are taken by mouth and as a solution that can be injected into the vein for the treatment of fungal infections. Administering voriconazole by inhalation is a new way of giving the medicine which is why it is being tested in this study. It is believed that this new way of administration will improve direct treatment of ABPA by allowing more of the medicine to get directly into the lungs where it is needed most.
This 3 part study will look at safety, tolerability and study drug levels following single and multiple doses of ZP-059.
- Part 1 will look at single doses of ZP-059 in approximately 24 healthy participants.
- Part 2 will look at multiple doses of ZP-059 in approximately 18 participants with mild asthma. Participants will take the study medication either once or twice daily for 10 days.
- Part 3 will look at single doses of ZP-059 and single doses of an oral formulation (tablet form) of voriconazole in approximately 16 participants with mild to moderate asthma.REC name
North East - York Research Ethics Committee
REC reference
20/NE/0002
Date of REC Opinion
23 Jan 2020
REC opinion
Further Information Favourable Opinion