AZD5423 Multiple Ascending Dose Study

AstraZeneca27 enrolled

Overview

The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5423 following multiple ascending dose administrations in healthy male and female subjects

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

AZD5423DRUG

Suspension for nebulisation, inhaled. Each subject will receive an inhaled dose of AZD5423 or placebo once daily for 14 days. Starting dose as determined from SAD study and with up to 4 dose escalations not exceeding AstraZeneca pre-defined exposure limits.

PlaceboDRUG

Solution for nebulisation, inhaled. Each subject will receive an inhaled dose of AZD5423 or placebo once daily for 14 days.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures * Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg Exclusion Criteria: * Any clinically significant disease or disorder * Any clinically significant abnormalities at screening examination * Use of any prescribed or non-prescribed medication

Locations (1)

Research Site

London Bridge, Greater London, United Kingdom

Outcomes

Primary Outcomes

Safety variables: adverse events

Time frame: Assessment taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and follow-up visit. Volunteers will be monitored throughout the study for adverse events.

Secondary Outcomes

Pharmacokinetics profile: concentration of AZD5423 in plasma

Time frame: Samples taken at defined timepoints pre-dose and post-dose during treatment periods. Samples taken at approx. 39 timepoints.

Investigation of PD effects

Time frame: Samples taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and follow-up.

Data from ClinicalTrials.gov

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