Safety and Tolerability of Single and Multiple Doses of VAK694 in Healthy and Atopic Subjects

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00620230

First received: February 7, 2008

Last updated: September 24, 2010

Last verified: September 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

February 7, 2008

Last Updated Date

September 24, 2010

Start Date ^ICMJE

October 2007

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Routine safety observations and pharmacokinetic measurements [ Time Frame: throughout the study ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00620230 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Routine safety observations and pharmacokinetic measurements [ Time Frame: throughout the study ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety and Tolerability of Single and Multiple Doses of VAK694 in Healthy and Atopic Subjects

Official Title ^ICMJE

A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetic Profile and Pharmacodynamic Effect of Single and Multiple Doses of VAK694 in Healthy and Atopic Subjects

Brief Summary

This study will evaluate the safety and tolerability of single and multiple doses of VAK694 in healthy volunteers and otherwise healthy volunteers with a history of allergies.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)

Condition ^ICMJE

Allergic Rhinitis

Intervention ^ICMJE

Drug: NVP-VAK694

Study Arm (s)

Experimental: 1
Intervention: Drug: NVP-VAK694
Placebo Comparator: 2
Intervention: Drug: NVP-VAK694

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

April 2008

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

History of allergic rhinitis (Part 2 only)

Exclusion Criteria:

Very low or high body weight
Heavy or recent smoker
Exposure to human monoclonal antibodies

Other protocol-defined inclusion/exclusion criteria may apply.

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00620230

Other Study ID Numbers ^ICMJE

CVAK694A2102

Has Data Monitoring Committee

Responsible Party

Novartis

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Novartis

Novartis investigator site

Information Provided By

Novartis

Verification Date

September 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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