A Study of the Safety and How the Body Effects a Drug CNTO 136 in Healthy Male Japanese and Caucasian Volunteers

NCT00844909 | Completed Phase 1

• 1 other identifier: CR015910
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and how the body affects the drug CNTO 136 in healthy Japanese and Caucasian volunteers.

Conditions

Healthy

Keywords

CNTO 136; safety; pharmacokinetics; healthy Japanese; healthy Caucasian; Phase I; antibody; male.

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of a single SC administration of CNTO 136 in healthy Japanese and Caucasian volunteers

Secondary Outcomes (1)

• Pharmacokinetics and immunogenicity of a single SC administration of CNTO 136.

Interventions

CNTO 136 DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Demonstrate an understanding of the study and sign an informed consent form
• Healthy with no clinically relevant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments including complete blood count (CBC), coagulation tests, urinalysis, measurement of vital signs, and ECG
• Japanese volunteers must have been born in Japan, have resided outside of Japan for no more than 5 years, and have Japanese parents and maternal and paternal grandparents. Caucasian subjects must have Caucasian parents
• Have a weight in the range of 60 kg to 90 kg (inclusive), body mass index (BMI) of 19 kg/m2 to 29 kg/m2
• Nonsmoker or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study.

You may not qualify if:

• Currently have, or have a history of, disease or dysfunction of the pulmonary, cardiovascular, endocrine, hematologic, neurological, immune, gastrointestinal, genitourinary, or other body system, that is clinically significant in the opinion of the investigator
• Have any underlying physical or psychological medical condition that, in the opinion of the investigator, would make it unlikely that the healthy volunteer will complete the study
• Have evidence of any chronic medical condition requiring prescription medications (eg, hypertension, elevated cholesterol/triglycerides, asthma, or diabetes)
• Currently have any known malignancy or have a history of malignancy
• Have had major or traumatic surgery within 12 weeks of screening or any surgery within 1 week.

Sponsors & Collaborators

• Centocor, Inc.: lead

MeSH Terms

Interventions

sirukumab

Study Officials

• Centocor, Inc. Clinical Trial

  Centocor, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 13, 2009
• First Posted: February 16, 2009
• Study Start: January 1, 2009
• Study Completion: August 1, 2009
• Last Updated: April 27, 2010

Record last verified: 2009-10