Safety, Tolerability and Pharmacokinetics of Multiple Doses of VAK694 in Atopic Subjects With Seasonal Rhinitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Brief Summary

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This study will assess the safety and tolerability of multiple doses of VAK694 as well as change in symptoms and biomarkers in patients with seasonal allergic rhinitis

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Detailed Description

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Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo to VAK694

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

VAK694

Group Type EXPERIMENTAL

VAK694

Intervention Type BIOLOGICAL

Fluticasone propionate

Group Type ACTIVE_COMPARATOR

Fluticasone

Intervention Type DRUG

Interventions

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Placebo

Intervention Type BIOLOGICAL

VAK694

Intervention Type BIOLOGICAL

Fluticasone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female subjects between ages of 18 to 60 in good health
* History of atopy for at least 2 years and positive skin prick test to ragweed allergen

Exclusion Criteria

* History of asthma treated with corticosteroids
* Smokers with a smoking history of \> 10 pack/years or smoking in the past year
* History of chronic obstructive pulmonary disease

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes