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Clinical Trials/NCT00421226
NCT00421226CompletedPhase 1

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

Novartis1 site in 1 country48 target enrollmentStarted: December 1, 2006Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Novartis
Enrollment
48
Locations
1
Primary Endpoint
Safety and tolerability

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
20 Years to 45 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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

  • 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

Outcomes

Primary Outcomes

Safety and tolerability

Secondary Outcomes

  • Pharmacokinetics and pharmacodynamics

Investigators

Sponsor
Novartis
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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