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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QGE031 Dose 1 | Experimental | QGE031 Dose 1: subcutaneous injection, single dose |
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| QGE031 Dose 2 | Experimental | QGE031 Dose 2: subcutaneous injection, single dose |
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| QGE031 Dose 3 | Experimental | QGE031 Dose 3: subcutaneous injection, single dose |
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| Placebo | Placebo Comparator | Placebo to QGE031 : subcutaneous injection, single dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QGE031 | Drug | QGE031 was supplied as liquid in 2 mL vial for subcutaneous injection. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Sagamihara | Kanagawa | 228-8520 | Japan |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| D001249 | Asthma |
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
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| ID | Term |
|---|---|
| C000598891 | ligelizumab |
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| Placebo | Drug | Placebo was supplied as liquid in 2 mL vial for subcutaneous injection. |
|
| 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 |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |