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AZD5423 Single Ascending Dose Study

NCT00963183 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2015-01-14

No results posted yet for this study

Summary

The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5423 following single ascending dose administrations in healthy male subjects.

Conditions

  • Healthy Volunteers

Interventions

DRUG

AZD5423

Solution for nebulisation, inhaled. Each subject will receive a single-dose of AZD5423 or placebo. Starting dose 8.4µg (lung deposited dose) with up to 8 dose escalations not exceeding AstraZeneca pre-defined exposure limits.

DRUG

Placebo

Solution for nebulisation, inhaled. Each subject will receive a single-dose.

Sponsors & Collaborators

Principal Investigators

  • Jorup Carin · AstraZeneca R&D, Lund, Sweden

  • Darren Wilbraham · Guy's Drug Research Unit, Quintiles Ltd, London, UK

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00963183 on ClinicalTrials.gov