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
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

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

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00620230     History of Changes
Other Study ID Numbers: CVAK694A2102
Study First Received: February 7, 2008
Last Updated: September 24, 2010
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014