Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Healthy Japanese Male Volunteers
Lead Sponsor:
Novartis
Conditions:
Healthy
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of ACZ885 administered via intravenous infusion and subcutaneous injection in healthy Japanese male volunteers.
Eligibility Criteria
Inclusion
- Japanese healthy male subjects age 20 to 45 years of age, and in good health
- At screening and baseline, the subjects must be in good health as determined by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis.
- Body mass index within the range of 18 to 28 kg/m2 and weigh 50 to 100 kg
Exclusion
- 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:
- fainting,
- low blood pressure when standing,
- abnormal heart rhythms
- acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00421226
Start Date
December 1 2006
End Date
December 1 2007
Last Update
April 30 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative site
Tokyo, Japan