Healthy Volunteers Clinical Trial
Official title:
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group, 2-part Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Inhaled Doses of AZD9819 in Healthy Subjects
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United Kingdom | Research Site | London |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes | |
Secondary | Pharmacokinetic variables of AZD9819 by assessment of drug concentrations in plasma | Multiple PK blood samples from pre-dose until 96 hours post last dose | No |
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