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

Allergic Rhinitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00620230
• Other study ID #: CVAK694A2102
• Status: Completed
• Phase: Phase 1
• First received: February 7, 2008
• Last updated: September 24, 2010
• Start date: October 2007
• Est. completion date: April 2008

Study information

• Verified date: September 2010
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Allergic Rhinitis

Intervention

Drug:
• NVP-VAK694

• NVP-VAK694

Locations

Country	Name	City	State
United States	Novartis Investigator Site	North Miami Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Routine safety observations and pharmacokinetic measurements		throughout the study
Secondary	Routine safety observations and pharmacokinetic measurements		throughout the study