NCT01166698

Single Centre, Double-blind, Single and Multiple Ascending Inhaled Doses of AZD9819 in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers
• Safety
• Tolerability

Interventions

Type	Name	Description
DRUG	AZD9819	Inhaled single doses of suspension via SPIRA nebuliser
DRUG	AZD9819	Inhaled multiple doses of suspension via SPIRA nebuliser, once daily for 10 (maximum 14) days
DRUG	Placebo	Inhaled doses of suspension via SPIRA nebuliser given either as single (Part A) or multiple doses (Part B)

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2010-07-21
• Last updated: 2011-11-09

Locations

1 site across 1 country: United Kingdom