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This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of ACZ885 administered via intravenous infusion and subcutaneous injection in healthy Japanese male volunteers.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACZ885 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics and pharmacodynamics |
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Inclusion Criteria:
Exclusion Criteria:
Smokers.
Use of any prescription drugs within 4 weeks prior dosing, or over-the-counter medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing. Acetaminophen is acceptable. Treatment of any biologics within three months prior to dosing. Having live vaccinations within six months prior to dosing.
Participation in any clinical investigation within 4 months prior to dosing.
Donation or loss of 400 mL or more of blood within 3 months; donation or loss of 200 mL or more of blood within 1 month; or donation of component blood within 2 weeks prior to participation.
Significant illness (sinusitis, pneumonia, cystitis, sepsis, etc) within two weeks prior to dosing.
A past personal or close family medical history of cardiac disorders
History of:
Clinically significant drug allergy or history and complication of atopic allergy (asthma, urticaria, eczematous dermatitis)
Known hypersensitivity to the study drug or similar drugs
Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or jeopardize participation in the study.
History of immunodeficiency diseases, including a positive HIV test result.
A positive Hepatitis B surface antigen (HBsAg), Hepatitis C or Syphilis test result.
Drug or alcohol abuse within the 12 months prior to dosing
Tuberculosis symptoms, complication of tuberculosis, contact with patients with suspected tuberculosis symptoms
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Investigator site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative site | Tokyo | Japan |
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| ID | Term |
|---|---|
| C541220 | canakinumab |
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