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Completed

NCT Number: NCT01596712

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity 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.

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Key information

Conditions

Allergy Asthma Bronchial Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site

Sagamihara, Kanagawa, 228-8520, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

QGE031

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Number of Patients with Adverse Events

    Time frame: Day 113

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

Secondary outcomes

  1. QGE031 serum concentration

    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

    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.

  2. Free and total IgE serum concentrations

    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

    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.

  3. FcεRI expression and IgE binding on basophiles

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

    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.

  4. Immunogenicity (Anti-QGE031 antibody in serum)

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

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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 11, 2012
Registry last updated
Nov 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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