Phase 1 Three Part SAD, MAD & Cross-Over Study of PUR1900 (QCL118173)
Research type
Research Study
Full title
A Phase 1, Three-Part, Multi-Centre, Open-Label Study to Assess the Safety, Tolerability and Pharmacokinetics of Single (Part 1) and Multiple Doses (Part 2) of Itraconazole Administered as a Dry Powder for Inhalation (PUR1900) in Healthy Subjects and a Two-Period Crossover Study of Single Doses of Itraconazole administered as a Dry Powder for Inhalation (PUR1900) and an Oral Solution (Sporanox®) in Adult Subjects with Mild to Moderate Stable Asthma (Part 3)
IRAS ID
236851
Contact name
David Hava
Contact email
Sponsor organisation
Pulmatrix Inc.
Eudract number
2017-004449-25
Duration of Study in the UK
0 years, 3 months, 10 days
Research summary
The Sponsor is developing the study drug, PUR1900, for the potential treatment of allergic bronchopulmonary aspergillosis (ABPA). Typically the immune system of people with this condition have an exaggerated response (an overly sensitive response) within the body to a fungus called Aspergillus. Exposure to Aspergillus is unavoidable.
The study will try to identify the level of study drug, PUR1900, present in the blood following single and multiple doses of PUR1900. The safety and tolerability of PUR1900 will also be assessed.
The study is a multi-site, 3 part study. In Part 1, up to 18 healthy subjects will be enrolled to 3 cohorts. Each subject will receive one dose of PUR1900; with the dose increasing per cohort. Part 2 is a multiple ascending dose study, with up to 12 healthy subjects in 2 cohorts. Subjects will receive a once daily dose of PUR1900 for up to 14 days, with the dose increasing for cohort 2. An optional cohort may be added in Part 1 and 2. Part 3 will enroll up to 16 subjects with mild to moderate stable asthma. Subjects will be randomised to receive one dose of PUR1900 and one dose of Sporanox® oral solution. In Parts 1 and Part 3, subjects will be dosed on Day 1 and remain in clinic until Day 2. Subjects will attend a return visit on Days 3 and 5 and a follow-up visit 14 days after their last dose. For Part 3, subjects will also attend a return visit during the washout period between Period 1 and 2. In Part 2, subjects will be dosed on Day 1 to Day 14 and will remain in clinic until Day 15. Subjects will attend a return visit on Day 18 and 21 and attend a follow-up visit on Day 28 to check on their continued wellbeing.
REC name
HSC REC A
REC reference
17/NI/0241
Date of REC Opinion
12 Jan 2018
REC opinion
Further Information Favourable Opinion