To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ascending doses of inhaled AZD7594

Study identifier:D3740C00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Safety, Pharmacodynamics of AZD7594

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD7594, Placebo to match

Sex

Male

Actual Enrollment

175

Study type

Interventional

Age

18 Years - 45 Years

Date

Study Start Date: 01 Sept 2012

Primary Completion Date: 01 Jun 2013

Study Completion Date: 01 Jun 2013

Study design

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science

Verification:

Verified 01 May 2014 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Location

Research Site

London, United Kingdom

Arms	Assigned Interventions
Experimental: 1 Subjects will participate in 1 of up to 9 groups in Part A (single ascending dose part) or 1 of 4 groups in Part B (multiple ascending dose part). Ratio of subjects receiving AZD7594 versus placebo is 6:2 in part A and 6:3 in Part B.	Drug: AZD7594 Suspension inhaled via Spira nebuliser
Placebo Comparator: 2 Subjects will participate in 1 of up to 9 groups in Part A or 1 of 4 groups in Part B. Ratio of subjects receiving AZD7594 versus placebo is 6:2 in part A and 6:3 in Part B.	Drug: Placebo to match Matching placebo inhaled via Spira nebuliser

Documents available

CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

ClinicalTrialTransparency@astrazeneca.com

Contact Backup

Quintiles Drug Research Unit Call Centr

0800 634 1132

Investigators

Principal Investigator

Carin Jorup

AstraZeneca R&D, Molndal Sweden