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

Allergy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01596712
• Other study ID #: CQGE031A1101
• Status: Completed
• Phase: Phase 1
• First received: March 22, 2012
• Last updated: November 20, 2012
• Start date: March 2011
• Est. completion date: August 2012

Study information

• Verified date: November 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Allergy

Intervention

Drug:
• QGE031
QGE031 was supplied as liquid in 2 mL vial for subcutaneous injection.
• Placebo
Placebo was supplied as liquid in 2 mL vial for subcutaneous injection.

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Sagamihara	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	FceRI expression and IgE binding on basophiles	Blood will be collected to measure FceRI 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	No
Secondary	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	Yes