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

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Following Subcutaneous Injections of QGE031 in Japanese Atopic Male Subjects

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.

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.