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AZD5423 Multiple Ascending Dose Study

NCT01037504 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

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 multiple ascending dose administrations in healthy male and female subjects

Conditions

  • Healthy

Interventions

DRUG

AZD5423

Suspension for nebulisation, inhaled. Each subject will receive an inhaled dose of AZD5423 or placebo once daily for 14 days. Starting dose as determined from SAD study and with up to 4 dose escalations not exceeding AstraZeneca pre-defined exposure limits.

DRUG

Placebo

Solution for nebulisation, inhaled. Each subject will receive an inhaled dose of AZD5423 or placebo once daily for 14 days.

Sponsors & Collaborators

Principal Investigators

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

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

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United Kingdom

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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 NCT01037504 on ClinicalTrials.gov