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

Novartis

Status and phase: Completed; Phase 1

Conditions: Allergy

Treatments: Drug: QGE031; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01596712

CQGE031A1101

Details and patient eligibility

About

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.

Enrollment: 209 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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209 participants in 4 patient groups, including a placebo group

QGE031 Dose 1

Experimental group

Description:

QGE031 Dose 1: subcutaneous injection, single dose

Treatment:

Drug: QGE031

QGE031 Dose 2

Experimental group

Description:

QGE031 Dose 2: subcutaneous injection, single dose

Treatment:

Drug: QGE031

QGE031 Dose 3

Experimental group

Description:

QGE031 Dose 3: subcutaneous injection, single dose

Treatment:

Drug: QGE031

Placebo

Placebo Comparator group

Description:

Placebo to QGE031 : subcutaneous injection, single dose

Treatment:

Drug: Placebo