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

Phase 1CompletedNCT00620230

Novartis46 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Allergic Rhinitis

Interventions

NVP-VAK694DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Novartis Investigator Site

North Miami Beach, Florida, United States

Outcomes

Primary Outcomes

Routine safety observations and pharmacokinetic measurements

Time frame: throughout the study

Secondary Outcomes

Routine safety observations and pharmacokinetic measurements

Time frame: throughout the study

Data from ClinicalTrials.gov

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