AZD5423 Multiple Ascending Dose Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-04-30

Brief Summary

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The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5423 following multiple ascending dose administrations in healthy male and female subjects

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A

Drug: AZD5423

Group Type EXPERIMENTAL

AZD5423

Intervention Type DRUG

Suspension for nebulisation, inhaled. Each subject will receive an inhaled dose of AZD5423 or placebo once daily for 14 days. Starting dose as determined from SAD study and with up to 4 dose escalations not exceeding AstraZeneca pre-defined exposure limits.

B

Drug: Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Solution for nebulisation, inhaled. Each subject will receive an inhaled dose of AZD5423 or placebo once daily for 14 days.

Interventions

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AZD5423

Suspension for nebulisation, inhaled. Each subject will receive an inhaled dose of AZD5423 or placebo once daily for 14 days. Starting dose as determined from SAD study and with up to 4 dose escalations not exceeding AstraZeneca pre-defined exposure limits.

Intervention Type DRUG

Placebo

Solution for nebulisation, inhaled. Each subject will receive an inhaled dose of AZD5423 or placebo once daily for 14 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion Criteria

* Any clinically significant disease or disorder
* Any clinically significant abnormalities at screening examination
* Use of any prescribed or non-prescribed medication

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes