Clinical Trials/NCT01596712

NCT01596712

Completed

Phase 1

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

Novartis Pharmaceuticals1 site in 1 country209 target enrollmentMarch 2011

ConditionsAllergy

InterventionsQGE031 Placebo

DrugsQGE031 Placebo

Overview

Phase: Phase 1
Intervention: QGE031
Conditions: Allergy
Sponsor: Novartis Pharmaceuticals
Enrollment: 209
Locations: 1
Primary Endpoint: Number of Patients with Adverse Events
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2011

End Date

August 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

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.

Arms & Interventions

QGE031 Dose 1

QGE031 Dose 1: subcutaneous injection, single dose

Intervention: QGE031

QGE031 Dose 2

QGE031 Dose 2: subcutaneous injection, single dose

Intervention: QGE031

QGE031 Dose 3

QGE031 Dose 3: subcutaneous injection, single dose

Intervention: QGE031

Placebo

Placebo to QGE031 : subcutaneous injection, single dose

Intervention: Placebo

Outcomes

Primary Outcomes

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

QGE031 serum concentration(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(Pre-dose, 2, 4, 12, 24, 48, and 96 h post-dose, Days 8, 15, 22, 29, 43, 57, 71, 85, 99 and 113)
Immunogenicity (Anti-QGE031 antibody in serum)(Pre-dose, Days 29, 57 and 113)
FcεRI expression and IgE binding on basophiles(Pre-dose, 2, 24, 48, 96 h post-dose; Days 8, 15, 22, 29, 43, 57, 71, 85, 99, and 113)