AZD7325 Japan Multiple Ascending Dose (MAD) Study (JMAD)

AstraZeneca

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: AZD7325; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00945425

D1140C00015

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability after repeated ascending doses of AZD7325 in Japanese healthy male subjects.

Enrollment: 48 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Japanese subjects

Exclusion criteria

• Significant illness, as judged by the investigator, within 2 weeks of Day 1
• Enrollment in another concurrent investigational study or intake of an investigational drug within 4 months prior to the screening visit
• Blood loss in excess of 200 mL within 30 days of Day 1, in excess of 400 mL within 90 days of Day 1, or in excess of 1200 mL within 1 year of Day 1
• Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator and/or sponsor

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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48 participants in 4 patient groups

1

Experimental group

Description:

Low dose or placebo, twice daily

Treatment:

Drug: Placebo

Drug: AZD7325

2

Experimental group

Description:

Low dose or placebo, once daily

Treatment:

Drug: Placebo

Drug: AZD7325

3

Experimental group

Description:

Middle dose or placebo, twice daily

Treatment:

Drug: Placebo

Drug: AZD7325

4

Experimental group

Description:

High dose or placebo, once daily

Treatment:

Drug: Placebo

Drug: AZD7325