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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double
  • Study Primary Completion Date: October 2007

Interventions

  • Drug: ACZ885

Clinical Trial Outcome Measures

Primary Measures

  • Safety and tolerability

Secondary Measures

  • Pharmacokinetics and pharmacodynamics

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 20 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Novartis
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Novartis, Principal Investigator, Investigator site

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.