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

Novartis

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: ACZ885

Study type

Interventional

Funder types

Industry

Identifiers

NCT00421226

CACZ885A1101

Details and patient eligibility

About

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

Enrollment

48 estimated patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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