AZD5634 is an inhaled epithelial sodium channel (ENaC) inhibitor, currently being developed by AstraZeneca, that blocks the sodium channel in airway cells. By inhibiting this channel, AZD5634 may help to rehydrate the mucus that accumulates in the lungs of people with CF, making it thinner and easier to clear.1
Clinical trials involving AZD5634
AstraZeneca is preparing to start a Phase 1b study that will assess the safety, tolerability, and pharmacokinetic properties of inhaled AZD5634, as well as its effects on mucociliary clearance (MCC) in CF patients, after a single-dose administration of AD5634 (NCT02950805) compared to a single administration of a placebo. The trial, set to take place at three U.S. sites, is not yet recruiting participants.
Its primary objective is to measure the amount (in percentage) of average whole lung particle clearance up to 60 minutes following a single administration of aerosolized radiolabeled particles of AZD5634 in people with CF. Check here for the study’s contacts and locations.
A separate Phase 1 first-in-human single ascending dose study (NCT02679729) to better understand the safety, tolerability and pharmacokinetics of inhaled and intravenous AZD5634 in healthy volunteers was completed in October 2016. Its primary objectives included the frequency of adverse events up to two months after the final dose, and an assessment of changes from baseline in a wide set of health measures (including heart rate, blood rate, pulse oximetry, respiratory rate, body temperature, electrocardiogram, blood tests, physical examination, spirometry and urine evaluations).
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