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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 21, 2014