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

A Randomised, Placebo-controlled Single-blind, Single-centre Phase I Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Inhaled Doses of AZD4818 in Healthy Japanese Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00687232

Enrollment

Registered

2008-05-30

Start date

2008-01-31

Completion date

2008-05-31

Last updated

2010-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Phase I, Japan, Japanese, inhalation

Brief summary

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

Interventions

DRUGAZD4818

Dry powder, inhalation, b.i.d, 10 + 1/2 days or 20 + 1/2 days

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Incidence and nature of adverse Event, 12-lead ECG, BP, pulse rate, body temperature, spirometry	During the study
Lab assessment	During the study

Secondary

Measure	Time frame
Pharmacokinetics	During the study

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026