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A First Time in Man Study to Asses the Safety and Tolerability of AZD7624 in Healthy Subjects

NCT01754844 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2015-04-02

No results posted yet for this study

Summary

This is a First in Human study to assess the safety and tolerability of AZD7624, following inhaled administration of single ascending doses in healthy male volunteers and female volunteers of non-child bearing potential. Pharmacokinetics (what the body does to the drug) and pharmacodynamic (what the drug does to the body) parameters will be also assessed as secondary objectives.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

AZD7624

Single dose inhaled IMP via a nebulizer

DRUG

Placebo to match

Single dose inhaled Placebo via a nebulizer

Sponsors & Collaborators

Principal Investigators

  • Sam Lindgren, MD · AstraZeneca Research and Development SE-431 83 Molndal Sweden

  • Darren G Wilbraham · Quintiles Drug Research Unit at Guy's Hospital 6 Newcomen St London SE1 1YR

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT01754844 on ClinicalTrials.gov