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

Phase 1

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: NVP-VAK694

• Registration Number: NCT00620230
• Lead Sponsor: Novartis

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-02-07
• Study First Submitted QC: 2008-02-07
• Study First Posted: 2008-02-21
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-24
• Last Update Posted: 2010-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	NVP-VAK694	-
2	NVP-VAK694	-

Primary Outcome Measures

Name	Time	Method
Routine safety observations and pharmacokinetic measurements	throughout the study

Secondary Outcome Measures

Name	Time	Method
Routine safety observations and pharmacokinetic measurements	throughout the study

Trial Locations

Locations (1)

Novartis Investigator Site; 🇺🇸 North Miami Beach, Florida, United States