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

Primary Purpose

Allergy

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

QGE031

Placebo

About this trial

This is an interventional basic science trial for Allergy focused on measuring Allergy,, Asthma,, Atopic dermatitis,, Japanese,, QGE031,, IgE

Eligibility Criteria

20 Years - 55 Years (Adult)MaleAccepts 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.

Sites / Locations

Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

QGE031 Dose 1

QGE031 Dose 2

QGE031 Dose 3

Placebo

Arm Description

QGE031 Dose 1: subcutaneous injection, single dose

QGE031 Dose 2: subcutaneous injection, single dose

QGE031 Dose 3: subcutaneous injection, single dose

Placebo to QGE031 : subcutaneous injection, single dose

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT01596712

First Posted

March 22, 2012

Last Updated

November 20, 2012

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01596712

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergy

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

209 (Actual)

8. Arms, Groups, and Interventions

Arm Title

QGE031 Dose 1

Arm Type

Experimental

Arm Description

QGE031 Dose 1: subcutaneous injection, single dose

Arm Title

QGE031 Dose 2

Arm Type

Experimental

Arm Description

QGE031 Dose 2: subcutaneous injection, single dose

Arm Title

QGE031 Dose 3

Arm Type

Experimental

Arm Description

QGE031 Dose 3: subcutaneous injection, single dose

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo to QGE031 : subcutaneous injection, single dose

Intervention Type

Drug

Intervention Name(s)

QGE031

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Patients with Adverse Events

Description

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

Time Frame

Day 113

Secondary Outcome Measure Information:

Title

QGE031 serum concentration

Description

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

Title

Free and total IgE serum concentrations

Description

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

Title

FcεRI expression and IgE binding on basophiles

Description

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.

Time Frame

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

Title

Immunogenicity (Anti-QGE031 antibody in serum)

Description

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

Time Frame

Pre-dose, Days 29, 57 and 113

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Sagamihara

State/Province

Kanagawa

ZIP/Postal Code

228-8520

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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