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

Novartis Pharmaceuticals209 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

209

Conditions

Allergy

Interventions

QGE031DRUG

QGE031 was supplied as liquid in 2 mL vial for subcutaneous injection.

PlaceboDRUG

Placebo was supplied as liquid in 2 mL vial for subcutaneous injection.

Eligibility

Sex: MALEMin age: 20 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Novartis Investigative Site

Sagamihara, Kanagawa, Japan

Outcomes

Primary Outcomes

Number of Patients with Adverse Events

Adverse events will be determined by evaluating clinical, laboratory evaluations, impact on vital signs and impacts on ECGs and other safety assessments.

Time frame: Day 113

Secondary Outcomes

QGE031 serum concentration

Blood will be collected for the determination of serum QGE031 concentrations. Cmax, Tmax, Area Under the curve (AUC), terminal half-life of serum QGE031. These parameters will be determined using non-compartmental methods.

Time frame: Pre-dose, 2, 4, 12, 24, 48, and 96 h post-dose, Days 8, 15, 22, 29, 43, 57, 71, 85, 99 and 113

Free and total IgE serum concentrations

Blood will be collected to measure serum IgE concentrations. Cmin, Tmin, and percent decrease of free IgE serum concentration will be determined. Cmax, Tmax, and percent increase of total IgE serum concentration will be determined.

Time frame: Pre-dose, 2, 4, 12, 24, 48, and 96 h post-dose, Days 8, 15, 22, 29, 43, 57, 71, 85, 99 and 113

FcεRI expression and IgE binding on basophiles

Blood will be collected to measure FcεRI expression and IgE binding on basophiles. Lots of individual values and mean values over time will be provided.

Time frame: Pre-dose, 2, 24, 48, 96 h post-dose; Days 8, 15, 22, 29, 43, 57, 71, 85, 99, and 113

Immunogenicity (Anti-QGE031 antibody in serum)

Blood will be collected to measure Immunogenicity. The number and percentage of subjects producing anti-QGE031 antibody will be presented.

Time frame: Pre-dose, Days 29, 57 and 113

Data from ClinicalTrials.gov

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