Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of QGE031 in Japanese Atopic Male Subjects

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of QGE031 in Japanese atopic male subjects in order to determine the eligibility of Japanese patients in subsequent clinical studies.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Male Japanese subjects who are atopic as determined by an in vitro test (CAP-RAST or MAST test)

• Serum IgE level must be equal to or greater than 30 IU/mL at screening.

Exclusion Criteria:

• Poorly controlled asthma i.e. symptoms of asthma (daytime or night-time) or use of short-acting beta agonist for relief of asthma (except with exercise) more than once a week

• Worsening of asthma signs and symptoms prompting a medical intervention within 1 year prior to dosing

• Severe atopic dermatitis within 1 year prior to dosing, defined by a history of eruption with severe inflammation such as erythema, papule, erosion, infiltration and lichen

• Severe allergic rhinitis strongly disturbing daily life within 1 year prior to dosing

• Severe allergic conjunctivitis (e.g., episodes of giant papillary, limbal proliferation, shield ulcer) within 1 year prior to dosing

• Prior use of Xolair® or other anti-IgE antibodies

• Concomitant use of allergy vaccination therapy

Other protocol-defined inclusion/exclusion criteria may apply.