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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: AZD1446; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01021189

D1950C00003

Details and patient eligibility

About

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.

Enrollment: 97 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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97 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

AZD1446

Treatment:

Drug: AZD1446

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo