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

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT00421226
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-01-10
• Study First Submitted QC: 2007-01-10
• Study First Posted: 2007-01-11
• Primary Completion: 2007-10
• Study Completion: 2007-12
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-27
• Last Update Posted: 2012-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety and tolerability

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics and pharmacodynamics

Trial Locations

Locations (1)

Novartis Investigative site; 🇯🇵 Tokyo, Japan