AZD Single Ascending Dose Study In Healthy Japanese Subjects

Study Overview
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Brief Summary
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This is a single centre, open label, non-randomised study to access the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD3043 following a single dose administration to Japanese subjects.

Official Title
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Phase I, Single Centre, Open Label Study to Access The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 After A) a Single Ascending Bolus Dose and B) a Single Ascending Bolus Dose Followed by a Single Infusion Dose in Healthy Japanese Volunteers (Age Range 20-45 Years)

Conditions
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Healthy

Intervention / Treatment
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* Drug: AZD3043
* Drug: AZD3043


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Japanese male and females of non-childbearing potential aged ≥20 to ≤ 45 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, 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. History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs Any clinically significant illness/infection or medical/surgical procedure or trauma, as judged by the Principal Investigator, within 4 weeks of the first administration of investigational product. Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis as judged by the Investigator

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD3043<br> | Drug: AZD3043<br>* Intravenous, single dose<br>Drug: AZD3043<br>* Infusion, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of AZD3043 following administration of SAD bolus (Part A) and SAD bolus followed by infusion (Part B). |  | From screening period to follow-up visit 42 days (Maximum) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the PK of AZD3043 and its main metabolite (THRX-108893) & provisionally assess the dose-proportionality of the PK |  | Blood and urine sampling from pre-dose until follow-up visit, 10 days (approximately) | 
| To evaluate the onset, level and recovery of/from sedation/anaesthesia. |  | Assessed on Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase I, AZD3043, Japanese healthy volunteer