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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00620230
First Posted: February 21, 2008
Last Update Posted: September 27, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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 ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT00620230     History of Changes
Other Study ID Numbers: CVAK694A2102
First Submitted: February 7, 2008
First Posted: February 21, 2008
Last Update Posted: September 27, 2010
Last Verified: September 2010

Keywords provided by Novartis:
Allergic rhinitis, anti-interleukin 4

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases