NCT01636024

To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of Inhaled AZD7594

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Ascending Inhaled Doses of AZD7594 in Healthy Male Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety profile and look at levels of AZD7594 and biomarkers in blood when the drug is administered inhaled to healthy subjects

Detailed description

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Ascending Inhaled Doses of AZD7594 in Healthy Male Volunteers

Conditions

• Safety
• Pharmacokinetics
• Pharmacodynamics of AZD7594

Interventions

Type	Name	Description
DRUG	AZD7594	Suspension inhaled via Spira nebuliser
DRUG	Placebo to match	Matching placebo inhaled via Spira nebuliser

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2012-07-10
• Last updated: 2013-06-20

Locations

1 site across 1 country: United Kingdom