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

NCT ID: NCT02074800

Last Updated: 2015-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2009-06-30

Brief 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.

Detailed Description

This is a single-dose and randomized (study medication is assigned by chance) study. This study will be conducted in 2 parts (Part 1 and Part 2). Approximately 144 participants will be enrolled in this study (24 participants in Part 1 and 120 participants in Part 2). Part 1 is the double-blind (neither physician nor participants know the treatment that the participant receives) and staggered parallel (a clinical study comparing the response in two or more groups of participants receiving different treatments) part of the study. Participants in Part 1 will receive either 1.4 or 2.8 mg/kg of either Sp2/0-derived CNTO 328 or CHO-derived CNTO 328 or placebo. Part 2 is the open-label (all people know the identity of the intervention) part of the study. Participants in Part 2 will receive 1.4 mg/kg of either Sp2/0-derived or CHO-derived CNTO 328. Safety will be evaluated by the assessment of adverse events, vital signs, physical examination, 12-lead electrocardiogram, and clinical laboratory tests which will be monitored throughout the study. The total duration of study participation for each participant will be approximately 199 days including a screening phase (within 30 days before the first study medication administration) and a treatment phase (inpatient [hospitalization period] 12 days and outpatient [follow-up] visits up to 169 days).

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Part 1

Participants will receive either 1.4 or 2.8 mg/kg of either Sp2/0-derived CNTO 328 or CHO-derived CNTO 328 or placebo.

Group Type: EXPERIMENTAL

CNTO 328 (Sp2/0-derived)

Intervention Type: DRUG

Participants will receive a single-dose of Sp2/0-derived CNTO 328 intravenously (into the vein) either 1.4 or 2.8 mg/kg in Part 1 and 1.4 mg/kg in Part 2.

CNTO 328 (CHO-derived)

Intervention Type: DRUG

Participants will receive a single-dose of CHO-derived CNTO 328 intravenously (into the vein) either 1.4 or 2.8 mg/kg in Part 1 and 1.4 mg/kg in Part 2.

Placebo

Intervention Type: DRUG

Participants will receive a single-dose of matching placebo intravenously in Part 1.

Part 2

Participants will receive 1.4 mg/kg of either Sp2/0-derived or CHO-derived CNTO 328.

Group Type: EXPERIMENTAL

CNTO 328 (Sp2/0-derived)

Intervention Type: DRUG

Participants will receive a single-dose of Sp2/0-derived CNTO 328 intravenously (into the vein) either 1.4 or 2.8 mg/kg in Part 1 and 1.4 mg/kg in Part 2.

CNTO 328 (CHO-derived)

Intervention Type: DRUG

Participants will receive a single-dose of CHO-derived CNTO 328 intravenously (into the vein) either 1.4 or 2.8 mg/kg in Part 1 and 1.4 mg/kg in Part 2.

Interventions

CNTO 328 (Sp2/0-derived)

Participants will receive a single-dose of Sp2/0-derived CNTO 328 intravenously (into the vein) either 1.4 or 2.8 mg/kg in Part 1 and 1.4 mg/kg in Part 2.

Intervention Type: DRUG

CNTO 328 (CHO-derived)

Participants will receive a single-dose of CHO-derived CNTO 328 intravenously (into the vein) either 1.4 or 2.8 mg/kg in Part 1 and 1.4 mg/kg in Part 2.

Intervention Type: DRUG

Placebo

Participants will receive a single-dose of matching placebo intravenously in Part 1.

Intervention Type: DRUG

Other Intervention Names

SILTUXIMAB; SILTUXIMAB

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centocor, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Centocor Clinical Trial

Role: STUDY_DIRECTOR

Centocor, Inc.

Locations

Lincoln, Nebraska, United States

Neptune City, New Jersey, United States

Countries

United States

Other Identifiers

C0328T08

Identifier Type: OTHER

Identifier Source: secondary_id

CR015271

Identifier Type: -

Identifier Source: org_study_id