Safety and Tolerability of Single and Multiple Doses of VAK694 in Healthy and Atopic Subjects - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00620230

Purpose

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.

Condition	Intervention	Phase
Allergic Rhinitis	Drug: NVP-VAK694	Phase I

Drug Information available for: Interleukin-4

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title:	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

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	46
Study Start Date:	October 2007
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: NVP-VAK694
2: Placebo Comparator	Drug: NVP-VAK694

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620230

Locations

United States, Florida
Novartis Investigator Site
North Miami Beach, Florida, United States, 33169

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Novartis

Novartis investigator site

More Information

Responsible Party:	Novartis ( Novartis )
Study ID Numbers:	CVAK694A2102
Study First Received:	February 7, 2008
Last Updated:	April 17, 2008
ClinicalTrials.gov Identifier:	NCT00620230
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Allergic rhinitis, anti-interleukin 4

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

Interleukin-4
Rhinitis
Healthy

Additional relevant MeSH terms:

Nose Diseases

ClinicalTrials.gov processed this record on January 16, 2009