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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group, 2-part Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Inhaled Doses of AZD9819 in Healthy Subjects

Conditions
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Healthy Volunteers, Safety, Tolerability

Intervention / Treatment
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* Drug: AZD9819
* Drug: AZD9819
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD9819<br>Inhaled suspension | Drug: AZD9819<br>* Inhaled single doses of suspension via SPIRA nebuliser<br>Drug: AZD9819<br>* Inhaled multiple doses of suspension via SPIRA nebuliser, once daily for 10 (maximum 14) days<br>* Other names: Part B (multiple ascending doses);|
| Placebo Comparator: Placebo<br>Inhaled suspension | Drug: Placebo<br>* Inhaled doses of suspension via SPIRA nebuliser given either as single (Part A) or multiple doses (Part B)<br>* Other names: Part A and B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (ECG variables, adverse events, blood pressure, pulse, body temp, safety lab) |  | Frequent safety measurements during the study from screening period to follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic variables of AZD9819 by assessment of drug concentrations in plasma |  | Multiple PK blood samples from pre-dose until 96 hours post last dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, tolerability, healthy, inhalation