AZD5423 Multiple Ascending Dose Study

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: AZD5423

Study type: Interventional

Funder types: Industry

Identifiers

NCT01037504

D2340C00002

EudraCT No: 2009-016611-38

Details and patient eligibility

About

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

Enrollment: 27 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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27 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Drug: AZD5423

Treatment:

Drug: AZD5423

B

Placebo Comparator group

Description:

Drug: Placebo

Treatment:

Drug: Placebo