Study to Investigate Safety, Tolerability and Pharmacokinetics With Single and Multiple Ascending Doses of AZD1446

Study Overview
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Brief Summary
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This study is designed to evaluate the safety, tolerability and PK of AZD1446 in Subjects when given as multiple dose administration for either 7 Days (Day 1 single dose, Day 2-6 multiple doses) in Part A and optionally at fractionated doses for 1 Day in Part B.

Official Title
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A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1446 in Male and Non-fertile Female, Young and Elderly Healthy Volunteers, After Oral Multiple Ascending Doses

Conditions
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Healthy

Intervention / Treatment
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* Drug: AZD1446
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-fertile female, young or elderly Subjects, aged ≥18 to ≤50 or ≥65 to ≤80 Body mass index (BMI) between 19 and 30 kg/m2 Clinically normal findings on physical examination Exclusion Criteria: History of any clinically significant disease or disorder History of severe allergy/hypersensitivity reactions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Part A single and multiple dose and part B fractionated dose | Drug: AZD1446<br>* Solution, oral single and multiple dose<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part A: to assess the safety and tolerability of AZD1446 following multiple ascending doses of an orally administered solution of AZD1446 in male and non-fertile female, young and elderly Healthy Volunteers, |  | during the whole study period, ca 50 days | 
| Part B: to assess the safety and tolerability of AZD1446 following administration of an oral solution of AZD1446 as fractionated doses during one day in male and non-fertile female, young and elderly Healthy Volunteers. |  | during the whole study period, ca 43 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part A: To determine the single and multiple dose PK of AZD1446 in male and non-fertile female Healthy Volunteers. |  | PK sampling taken at defined timepoints during residential period, 10 days for Part A and 4 days for Part B | 
| Part B: To mimic an extended release dosing regimen and determine the fractionated dosing PK of AZD1446 in male and non-fertile Healthy Volunteers. |  | PK sampling taken at defined timepoints during residential period, 10 days for Part A and 4 days for Part B | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MAD, NNR, to investigate safety and tolerability in a multiple ascending dose study in Healthy subjects, AZD1446