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

Novartis

Status and phase: Completed; Phase 1

Conditions: Allergic Rhinitis

Treatments: Drug: NVP-VAK694

Study type: Interventional

Funder types: Industry

Identifiers

NCT00620230

CVAK694A2102

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

46 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: NVP-VAK694

Drug: NVP-VAK694

2

Placebo Comparator group

Treatment:

Drug: NVP-VAK694

Drug: NVP-VAK694