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

February 7, 2008
September 24, 2010
October 2007
April 2008   (final data collection date for primary outcome measure)
Routine safety observations and pharmacokinetic measurements [ Time Frame: throughout the study ]
Same as current
Complete list of historical versions of study NCT00620230 on ClinicalTrials.gov Archive Site
Routine safety observations and pharmacokinetic measurements [ Time Frame: throughout the study ]
Same as current
Not Provided
Not Provided
 
Safety and Tolerability of Single and Multiple Doses of VAK694 in Healthy and Atopic Subjects
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Allergic Rhinitis
Drug: NVP-VAK694
  • Experimental: 1
    Intervention: Drug: NVP-VAK694
  • Placebo Comparator: 2
    Intervention: Drug: NVP-VAK694
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
April 2008
April 2008   (final data collection date for primary outcome measure)

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.

Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00620230
CVAK694A2102
No
Novartis
Novartis
Not Provided
Principal Investigator: Novartis Novartis investigator site
Novartis
September 2010

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