A Study to Assess the Safety and Pharmacokinetics of a Single Intravenous Administration of CNTO 328 Derived From 2 Different Cell Lines in Healthy Participants

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of Part 1 of this study is to assess the safety and tolerability of 2 dose levels (1.4 and 2.8 mg/kg) of CHO-derived CNTO 328 and Sp2/0-derived CNTO 328. The purpose of Part 2 of this study is to access the pharmacokinetics (what the body does to the study medication) comparability of the 1.4 mg/kg dose of CHO-derived CNTO 328 and Sp2/0-derived CNTO 328.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centocor, Inc.
• Treatments: Antibodies, Monoclonal; Siltuximab

Criteria

Inclusion Criteria:

• No clinically relevant abnormalities as determined by medical history, physical examination, blood parameters and having Body Mass Index (BMI) between 18.5 to 27 kg/m2 (BMI is calculated as weight [kilogram] divided by square of height [meter])

• Have an absolute neutrophil count of 2000 or more per cube millimeter at screening and one day before the study medication administration

• Agree to use adequate birth control measures for at least 100 days after study medication administration

• Agree not to use prescription medications (with the exception of hormonal contraceptives) within 14 days prior to study medication administration and through Day 85 of the study, unless approved by medical monitor

• Agree to limit caffeine/xanthine (eg, coffee, tea, chocolate, or caffeine-containing soft drinks) intake to less than 300 mg/day through Day 85 of the study

Exclusion Criteria:

• Have a current or past 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 a current or past history of thrombocytopenia (a low platelet count) or bleeding abnormality or elevations in triglycerides that require treatment

• Have evidence of any chronic medical condition requiring prescription medications (eg, hypertension, elevated cholesterol/triglycerides, asthma, or diabetes)

• Positive serology test for human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C virus antibody at screening

• Positive urine toxicology screen and substances of abuse, including but not limited to alcohol, cocaine, cannabinoids, phencyclidine, amphetamines, benzodiazepines, barbiturates, opiates, propoxyphene, and methadone