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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00421226
• Other study ID #: CACZ885A1101
• Status: Completed
• Phase: Phase 1
• First received: January 10, 2007
• Last updated: April 27, 2012
• Start date: December 2006
• Est. completion date: December 2007

Study information

• Verified date: April 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ACZ885

Locations

Country	Name	City	State
Japan	Novartis Investigative site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability
Secondary	Pharmacokinetics and pharmacodynamics