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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00620230 |
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 |
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 |
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 |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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 |
Allergic rhinitis, anti-interleukin 4 |
Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases |
Interleukin-4 Rhinitis Healthy |
Nose Diseases |