Study to Assess Safety, Tolerability and Pharmacokinetics After Single and Multiple Doses of AZD1446 to Japanese Subject
- Registration Number
- NCT01021189
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 97
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 AZD1446 AZD1446 2 Placebo Placebo
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Research Site
🇯🇵Fukuoka, Japan