Allergy
Conditions
Keywords
Allergy,, Asthma,, Atopic dermatitis,, Japanese,, QGE031,, IgE
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.
Interventions
DRUGQGE031
QGE031 was supplied as liquid in 2 mL vial for subcutaneous injection.
DRUGPlacebo
Placebo was supplied as liquid in 2 mL vial for subcutaneous injection.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 55 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients with Adverse Events | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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 | 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) | 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. |
Countries
Japan
Outcome results
None listed