AZD2423 Single Ascending Dose Study in Healthy Japanese Subjects

Study Overview
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Brief Summary
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This is a Phase I, single centre, randomised, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability and pharmacokinetics of AZD2423 following single ascending dose administration to healthy Japanese 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 Oral AZD2423 After Single Ascending Doses in Healthy Japanese Male and Non-Fertile Female Volunteers

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: AZD2423
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Japanese male and non-fertile female subjects aged ≥20 to ≤55 years with suitable veins for cannulation or repeated venepuncture. Body weight 45-90 kg and Body mass index (BMI) ≥18.0 and ≤27.0 kg/m2 Clinically normal physical findings including supine blood pressure, pulse rate, orthostatic blood pressure, ECG, and laboratory assessments in relation to age, as judged by the Investigator. Exclusion Criteria: History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study. Any clinically significant illness/infection or medical/surgical procedure or trauma, as judged by the Principal Investigator, within 3 months of the first administration of investigational product. Frequent use of tobacco or other nicotine containing products. Frequent use is defined as smoking or consumption/intake of nicotine products more than two days per week during the last 12 weeks.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. AZD2423<br> | Drug: AZD2423<br>* oral solution, single dose<br>|
| Placebo Comparator: 2. Placebo<br> | Drug: Placebo<br>* oral solution,single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To asses the safety: Adverse events, vital signs, electrocardiograms (ECGs), laboratory variables. |  | From screening period to follow-up visit, 40 days (Maximum). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the pharmacokinetics of AZD2423 in plasma and urine. |  | Blood and urine sampling from pre-dose until follow-up visit, 10 days (approximately) | 
| Exploratory endpoints;Levels of CCL2 pre-and post dose |  | Blood sampling after dosing, 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase I, Japanese healthy volunteer, AZD2423