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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00421226
First received: January 10, 2007
Last updated: April 27, 2012
Last verified: April 2012
  Purpose

This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of ACZ885 administered via intravenous infusion and subcutaneous injection in healthy Japanese male volunteers.


Condition Intervention Phase
Healthy
Drug: ACZ885
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Demonstrate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 Administered as Intravenous Infusion and Subcutaneous Injection in Japanese Healthy Volunteers

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Safety and tolerability

Secondary Outcome Measures:
  • Pharmacokinetics and pharmacodynamics

Estimated Enrollment: 48
Study Start Date: December 2006
Study Completion Date: December 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421226

Locations
Japan
Novartis Investigative site
Tokyo, Japan
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Investigator site
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00421226     History of Changes
Other Study ID Numbers: CACZ885A1101
Study First Received: January 10, 2007
Last Updated: April 27, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:
Safety, tolerability, pharmacokinetics, pharmacodynamics, ACZ885, Japanese,

ClinicalTrials.gov processed this record on July 20, 2014