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OpenTrials
Completed

NCT Number: NCT00620230

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

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.

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigator Site

North Miami Beach, Florida, 33169, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NVP-VAK694

Drug

Primary outcomes

  1. Routine safety observations and pharmacokinetic measurements

    Time frame: throughout the study

Secondary outcomes

  1. Routine safety observations and pharmacokinetic measurements

    Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 21, 2008
Registry last updated
Sep 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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