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

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

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.

Study Overview

• Status: Completed
• Conditions: Allergy
• Intervention / Treatment: Drug: QGE031; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 209
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Kanagawa
    • Sagamihara, Kanagawa, Japan, 228-8520
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 113

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Pre-dose, 2, 4, 12, 24, 48, and 96 h post-dose, Days 8, 15, 22, 29, 43, 57, 71, 85, 99 and 113
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.	Pre-dose, 2, 4, 12, 24, 48, and 96 h post-dose, Days 8, 15, 22, 29, 43, 57, 71, 85, 99 and 113
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.	Pre-dose, 2, 24, 48, 96 h post-dose; Days 8, 15, 22, 29, 43, 57, 71, 85, 99, and 113
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.	Pre-dose, Days 29, 57 and 113

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: March 22, 2012
• First Submitted That Met QC Criteria: May 9, 2012
• First Posted (Estimate): May 11, 2012

Study Record Updates

• Last Update Posted (Estimate): November 22, 2012
• Last Update Submitted That Met QC Criteria: November 20, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Asthma,; IgE; Japanese,; Allergy,; Atopic dermatitis,; QGE031,
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: CQGE031A1101