Single Centre, Double-blind, Single and Multiple Ascending Inhaled Doses of AZD9819 in Healthy Subjects

AstraZeneca100 enrolled

Overview

The purpose of the study is to assess safety and tolerability of AZD9819 following inhaled administration of single and multiple increasing doses, and to estimate the maximum dose that is tolerated in healthy people.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

100

Conditions

Healthy Volunteers Safety Tolerability

Interventions

AZD9819DRUG

Inhaled single doses of suspension via SPIRA nebuliser

AZD9819DRUG

Inhaled multiple doses of suspension via SPIRA nebuliser, once daily for 10 (maximum 14) days

PlaceboDRUG

Inhaled doses of suspension via SPIRA nebuliser given either as single (Part A) or multiple doses (Part B)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures * Healthy male and female (non-child bearing potential) subjects aged 18 to 50 years with suitable veins for cannulation or repeated venepuncture. * 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, United Kingdom

Outcomes

Primary Outcomes

Safety variables (ECG variables, adverse events, blood pressure, pulse, body temp, safety lab)

Time frame: Frequent safety measurements during the study from screening period to follow-up

Secondary Outcomes

Pharmacokinetic variables of AZD9819 by assessment of drug concentrations in plasma

Time frame: Multiple PK blood samples from pre-dose until 96 hours post last dose

Data from ClinicalTrials.gov

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