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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01596712
First Posted: May 11, 2012
Last Update Posted: November 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
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.

Condition Intervention Phase
Allergy Drug: QGE031 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official 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

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 209
Study Start Date: March 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QGE031 Dose 1
QGE031 Dose 1: subcutaneous injection, single dose
Drug: QGE031
QGE031 was supplied as liquid in 2 mL vial for subcutaneous injection.
Experimental: QGE031 Dose 2
QGE031 Dose 2: subcutaneous injection, single dose
Drug: QGE031
QGE031 was supplied as liquid in 2 mL vial for subcutaneous injection.
Experimental: QGE031 Dose 3
QGE031 Dose 3: subcutaneous injection, single dose
Drug: QGE031
QGE031 was supplied as liquid in 2 mL vial for subcutaneous injection.
Placebo Comparator: Placebo
Placebo to QGE031 : subcutaneous injection, single dose
Drug: Placebo
Placebo was supplied as liquid in 2 mL vial for subcutaneous injection.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01596712


Locations
Japan
Novartis Investigative Site
Sagamihara, Kanagawa, Japan, 228-8520
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01596712     History of Changes
Other Study ID Numbers: CQGE031A1101
First Submitted: March 22, 2012
First Posted: May 11, 2012
Last Update Posted: November 22, 2012
Last Verified: November 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Allergy,
Asthma,
Atopic dermatitis,
Japanese,
QGE031,
IgE