Safety Tolerability & PK Study of Inhaled Murepavadin in Healthy Subj
Research type
Research Study
Full title
A single-center, double-blind, randomized, placebo-controlled, 3-Part, parallel group, single- and multiple escalating doses, Phase 1 study to investigate safety, tolerability, and pharmacokinetics of inhaled murepavadin in healthy subjects.
IRAS ID
274427
Contact name
Chetty Rajkumar
Contact email
Sponsor organisation
Spexis AG
Eudract number
2020-004188-23
Duration of Study in the UK
0 years, 6 months, 30 days
Research summary
This is a Single-Center double-blind, randomized, placebo-controlled, 3-Part, parallel group, single- and multiple escalating doses, Phase 1 study to find out about the safety of Murepavadin, what is the highest dose subjects can inhale without experiencing any significant effects, how much Murepavadin is in the blood and urine, in the lung (parts 2 and 3 only) of subjects after breathing in the study drug and how Murepavadin affects the body.
Murepavadin (also known as POL7080) is being developed as an inhaled antibiotic for the purpose of treating chronic pseudomonas aeruginosa (lung infections) in patients with a specific type of genetic disease affecting the lungs called cystic fibrosis(CF).
Subjects must be male or female volunteer aged between 18 and 60 and assessed as healthy based on a screening examination including medical history, examination, vital signs, ECG assessment, pulmonary function testing (FEV1 must be > 80% of predicted), and clinical laboratory results, to a body mass index (BMI) between 18 and 32 kg/m2.This study will be conducted in three parts and will enroll around 51 subjects (6 in Part A, 27 in Part B, 18 in Part C).
All parts include up to 28 days for screening.The duration of the study for Part A is about 5 weeks. There will be 1 confinement period of 2 nights and 1 return visit.
For Part B, the entire study will last about 5 weeks. There will be a confinement period of 2 or 3 nights and 1 return visit. The length of the confinement will depend on the timepoint the subject is randomised to undergo a bronchoalveolar lavage (BAL) procedure.
For Part C, the entire study will last about 10 weeks. There will be a confinement period of 8 or 9 nights (depending on the timepoint the subject is randomised to undergo a BAL procedure), 1 return visit and 1 follow-up phone call.
REC name
HSC REC A
REC reference
20/NI/0127
Date of REC Opinion
2 Nov 2020
REC opinion
Further Information Favourable Opinion