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

NCT ID: NCT01596712

Last Updated: 2012-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

209 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-08-31

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.

Detailed Description

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Conditions

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Allergy

Keywords

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Allergy, Asthma, Atopic dermatitis, Japanese, QGE031, IgE

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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QGE031 Dose 1

QGE031 Dose 1: subcutaneous injection, single dose

Group Type EXPERIMENTAL

QGE031

Intervention Type DRUG

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

QGE031 Dose 2

QGE031 Dose 2: subcutaneous injection, single dose

Group Type EXPERIMENTAL

QGE031

Intervention Type DRUG

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

QGE031 Dose 3

QGE031 Dose 3: subcutaneous injection, single dose

Group Type EXPERIMENTAL

QGE031

Intervention Type DRUG

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

Placebo

Placebo to QGE031 : subcutaneous injection, single dose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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QGE031

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Sagamihara, Kanagawa, Japan

Site Status

Countries

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Japan

Other Identifiers

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CQGE031A1101

Identifier Type: -

Identifier Source: org_study_id