Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Healthy Japanese Male Volunteers

NCT ID: NCT00421226

Last Updated: 2012-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2007-12-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

ACZ885

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 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:

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis

Role: PRINCIPAL_INVESTIGATOR

Investigator site

Locations

Novartis Investigative site

Tokyo, , Japan

Countries

Japan

Other Identifiers

CACZ885A1101

Identifier Type: -

Identifier Source: org_study_id