Study to Assess Safety, Tolerability and Pharmacokinetics After Single and Multiple Doses of AZD1446 to Japanese Subject

A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1446 in Healthy Young and Elderly Japanese Volunteers After Oral Single and Multiple Ascending Doses

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01021189

Enrollment

Registered

2009-11-26

Start date

2009-12-31

Completion date

2010-06-30

Last updated

2010-06-10

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

Conditions

Healthy

Keywords

safety, tolerability, AZD1446, AD, Japanese

Brief summary

The primary aim of this study is to assess the safety and tolerability of AZD1446 following single and multiple ascending doses of an orally administered solution of AZD1446 in healthy young and elderly Japanese subjects.

Interventions

DRUGAZD1446

Oral solution Dose single and followed by 7-day multiple dosing.Specific doses depend on panel.

DRUGPlacebo

Oral solution Dose single and followed by 7-day multiple dosing.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy Japanese subjects, aged ≥20 to ≤50 years for male young subjects, ≥65 to ≤80 years for male or post-menopausal female elderly subjects. * BMI between 18 and 27 kg/m2 and weigh at least 50 kg and no more than 90 kg (for the elderly female, weigh at least 45 kg and no more than 90 kg).

Exclusion criteria

* History of Quincke oedema or angiooedema, or history of repeated episodes of urticaria. * History or present symptoms or signs of asthma, airway hyperreactivity or obstructive lung disease.

Design outcomes

Primary

Measure	Time frame
To assess the safety and tolerability of AZD1446 following single and multiple ascending doses of an orally administered solution of AZD1446 in healthy young and elderly Japanese subjects by adverse events, vital signs, laboratory variables and ECG.	During the whole study period, ca. 50 days.

Secondary

Measure	Time frame
To determine pharmacokinetics(PK) of AZD1446 following single and multiple dosing of AZD1446 in healthy young and elderly Japanese subjects.	PK sampling taken at defined timepoints during residential period, 12 days.

Countries

Japan

Outcome results

None listed

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