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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Allergy

Intervention / Treatment
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* Drug: QGE031
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: QGE031 Dose 1<br>QGE031 Dose 1: subcutaneous injection, single dose | Drug: QGE031<br>* QGE031 was supplied as liquid in 2 mL vial for subcutaneous injection.<br>|
| Experimental: QGE031 Dose 2<br>QGE031 Dose 2: subcutaneous injection, single dose | Drug: QGE031<br>* QGE031 was supplied as liquid in 2 mL vial for subcutaneous injection.<br>|
| Experimental: QGE031 Dose 3<br>QGE031 Dose 3: subcutaneous injection, single dose | Drug: QGE031<br>* QGE031 was supplied as liquid in 2 mL vial for subcutaneous injection.<br>|
| Placebo Comparator: Placebo<br>Placebo to QGE031 : subcutaneous injection, single dose | Drug: Placebo<br>* Placebo was supplied as liquid in 2 mL vial for subcutaneous injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 113 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Pre-dose, Days 29, 57 and 113 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergy,, Asthma,, Atopic dermatitis,, Japanese,, QGE031,, IgE