Single Centre, Double-blind, Single and Multiple Ascending Inhaled Doses of AZD9819 in Healthy Subjects
Phase 1
Completed
- Conditions
- Healthy VolunteersSafetyTolerability
- Interventions
- Drug: Placebo
- Registration Number
- NCT01166698
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of the study is to assess safety and tolerability of AZD9819 following inhaled administration of single and multiple increasing doses, and to estimate the maximum dose that is tolerated in healthy people.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Provision of signed and dated, written informed consent prior to any study specific procedures
- Healthy male and female (non-child bearing potential) subjects aged 18 to 50 years with suitable veins for cannulation or repeated venepuncture.
- Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg
Exclusion Criteria
- Any clinically significant disease or disorder
- Any clinically significant abnormalities at screening examination
- Use of any prescribed or non-prescribed medication
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Inhaled suspension AZD9819 AZD9819 Inhaled suspension
- Primary Outcome Measures
Name Time Method Safety variables (ECG variables, adverse events, blood pressure, pulse, body temp, safety lab) Frequent safety measurements during the study from screening period to follow-up
- Secondary Outcome Measures
Name Time Method Pharmacokinetic variables of AZD9819 by assessment of drug concentrations in plasma Multiple PK blood samples from pre-dose until 96 hours post last dose
Trial Locations
- Locations (1)
Research Site
🇬🇧London, United Kingdom