Safety, Tolerability and Pharmacokinetics of Inhaled Doses of AZD4818 in Healthy Japanese Male Volunteers

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AZD4818; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00687232

D3540C00010

Details and patient eligibility

About

The purpose is to investigate safety and tolerability of single and multiple ascending inhaled doses of AZD4818 in healthy Japanese male volunteers.

Enrollment: 30 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of informed consent
• Body Mass Index (BMI) between 18.0-27.0 kg/m2
• No clinically relevant abnormal findings

Exclusion criteria

• Acute illness which requires medical intervention
• Definite or suspected personal history of adverse drug reactions or drug hypersensitivity.
• Clinical relevant disease or disorder (past or present)
• A history of respiratory disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

AZD4818

Treatment:

Drug: AZD4818

2

Placebo Comparator group

Treatment:

Drug: Placebo