AZD9164 Single Ascending Dose Study in Healthy Male Subjects

NCT00847249 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2009-09-23

No results posted yet for this study

Summary

The aims of the study are to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD9164 following single ascending dose administrations to healthy male subjects.

Conditions

  • Healthy

Interventions

DRUG

AZD9164

Each subject will receive a single-dose starting dose 4µg (lung deposited dose) with up to 8 dose escalations not exceeding AstraZeneca pre-defined exposure limits.

DRUG

Placebo

Each subject will receive a single-dose.

Sponsors & Collaborators

Principal Investigators

  • Anders Luts · AstraZeneca

  • Ulf Malmqvist · Clinical Trial Unit, Clinical Research and Trial Centre, Lund University Hospital, Lund, Sweden

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
2009-02-28
Completion
2009-04-30

Countries

  • Sweden

Study Locations

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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 NCT00847249 on ClinicalTrials.gov