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Phase 1 Three Part SAD, MAD & Cross-Over Study of ZP-059 in Healthy and Asthmatic Subjects

2020-01-21 11:31:59 | BioPortfolio

Summary

This is an integrated Phase 1, single centre, multi-part, open-label study in both healthy subjects (Part 1), subjects with mild stable asthma (Part 2) and subjects with mild to moderate stable asthma (Part 3). In all parts of the study (i.e. Parts 1, 2 and 3) every effort will be made to include as close as possible an equal balance between male and female subjects; in Part 1 and Part 2 this will be in each of the individual cohorts.

Safety, tolerability and PK will be assessed following either single ascending (SAD) or multiple ascending (MAD) dosing of ZP-059; Part 1 and Part 2, respectively.

Study Design

Conditions

Allergic Bronchopulmonary Aspergillosis

Intervention

Voriconazole inhaled (ZP-059), Cross-over with VFEND

Location

Medicines Evaluation Unit Ltd. (MEU)
Manchester
United Kingdom
M239QZ

Status

Not yet recruiting

Source

Zambon SpA

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-01-21T11:31:59-0500

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The term allergy is used to describe a response, within the body, to a substance, which is not necessarily harmful in itself, but results in an immune response and a reaction that causes symptoms and disease in a predisposed person, which in turn can cau...


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