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

NCT ID: NCT00620230

Last Updated: 2010-09-27

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

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-04-30

Brief Summary

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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

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Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

NVP-VAK694

Intervention Type DRUG

2

Group Type PLACEBO_COMPARATOR

NVP-VAK694

Intervention Type DRUG

Interventions

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NVP-VAK694

Intervention Type DRUG

NVP-VAK694

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis

Principal Investigators

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Novartis

Role: PRINCIPAL_INVESTIGATOR

Novartis investigator site

Locations

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Novartis Investigator Site

North Miami Beach, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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CVAK694A2102

Identifier Type: -

Identifier Source: org_study_id