This is a Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of AZD9742 After Single IV Doses in Healthy Subjects

Study Overview
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Brief Summary
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The main purpose of this study is to assess the safety, tolerability and PK of AZD9742 after single IV doses.

Official Title
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A Phase-1, Single Center, Double Blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Intravenous AZD9742 After Single Ascending Doses in Healthy Male and Female Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: AZD9742
* Drug: Placebo to match AZD9742


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. Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG. Healthy male and female volunteers. Females must be of non childbearing potential. Exclusion Criteria: Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 4 weeks of the first administration of the Investigational Product History of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs

Ages Eligible for Study
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Minimum Age: 23 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD9742 IV Infusion<br>Active | Drug: AZD9742<br>* Increasing single IV infusion doses of AZD9742 given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo). Specific doses will be selected by the safety review committee<br>|
| Placebo Comparator: Placebo to AZD9742 IV Infusion<br>Placebo | Drug: Placebo to match AZD9742<br>* Single IV infusion of AZD9742 placebo given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of AZD9742 will be assessed by incidence and severity of AE's, abnormalities in vital signs, ECG's, telemetry, clinical laboratory assessments, physical exams and withdrawals |  | Assessments taken at Visit 1 (enrollment), defined timepoints pre-dose and post-dose during Visit 2 (residential period) and at Visit 3 (follow up). Volunteers will be monitored througout the study from Visit 1 through Visit 3 for adverse events. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profile: to characterize the pharmacokinetics of AZD9742 in blood and urine |  | Samples taken during Visit 2 (residential period) at defined timepoints pre-dose and post-dose. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteer, First time in human