AZD8683 Single Ascending Dose Study

Study Overview
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Brief Summary
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The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD8683 following single ascending dose administrations in healthy male subjects.

Official Title
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A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled AZD8683 After Single Ascending Doses in Healthy Male Subjects

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: AZD8683
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed, written and dated informed consent prior to any study specific procedures Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start Exclusion Criteria: Any clinically significant disease or disorder Any clinically significant abnormalities at screening examinations Use any prescribed or non-prescribed medication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>AZD8683 | Drug: AZD8683<br>* Solution for nebulisation, inhaled. Each subject will receive a single-dose of AZD8683 or placebo. Starting dose 1 ug (lung deposited dose) with up to 8 dose escalation not exceeding AstraZeneca pre-defined exposure limits.<br>|
| Placebo Comparator: B<br>Placebo | Drug: Placebo<br>* Solution for nebulisation, inhaled<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab) |  | Frequent sampling occasions during study days, before and up to 48 h after dosing, and at a follow-up visit 7-13 days after dosing. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Maximum plasma concentration (Cmax), time to Cmax (tmax), terminal rate constant (λz), terminal half-life (t½λz) |  | Frequent sampling occasions during study days, before and up to 48 h after dosing. | 
| Pharmacokinetics: Area under the plasma concentration-time curve from zero to the time of the last measurable concentration (AUC(0-t)) and from zero to infinity (AUC), apparent plasma clearance (CL/F) |  | Frequent sampling occasions during study days, before and up to 48 h after dosing. | 
| Pharmacokinetics: Apparent volume of distribution during terminal phase (Vz/F), mean residence time (MRT), amount of drug excreted unchanged (Ae; % dose), and renal clearance (CLR). |  | Frequent sampling occasions during study days, before and up to 48 h after dosing. | 
| Pharmacodynamics: Lung function by spirometry (forced expiratory volume in the first second [FEV1] and forced vital capacity [FVC]), blood pressure, pulse, QTc, and heart rate. |  | Frequent sampling occasions during study days, before and up to 48 h after dosing. | 

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