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

NCT02074800 | Completed Phase 1

• 2 other identifiers: CR015271C0328T08
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Keywords

Healthy; CNTO 328; Sp2/0-derived CNTO 328; CHO-derived CNTO 328; Safety; Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• Number of participants with adverse events as a measure of safety and tolerability in Part 1

  Up to Day 199

• Maximum observed serum concentration (Cmax) of CNTO 328 in Part 2

  This sample will be used for pharmacokinetics analysis. Cmax is defined as the maximum observed analyte concentration.

  Day 1 (predose, end of infusion, and postdose at Hours 1, 2, 4, and 8), Days 2 to 6, and Days 8, 15, 22, 29, 36, 43, 50, 71, and 85

• Area under the serum concentration-time curve from Day 0 to Day 84 (AUC 0-84D) of CNTO 328 in Part 2

  This sample will be used for pharmacokinetics analysis. AUC 0-84D is a measure of the serum concentration of the study medication over time. It is used to characterize drug absorption.

  Day 1 (predose, end of infusion, and postdose at Hours 1, 2, 4, and 8), Days 2 to 6, and Days 8, 15, 22, 29, 36, 43, 50, 71, and 85

Secondary Outcomes (2)

• Number of participants with adverse events as a measure of safety and tolerability in Part 2

  Up to Day 199

• Immune response of CNTO 328 in Part 1 and Part 2

  Day 1 (predose), Days 85, 113, and 169

Study Arms (2)

Part 1

EXPERIMENTAL

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.

Drug: CNTO 328 (Sp2/0-derived); Drug: CNTO 328 (CHO-derived); Drug: Placebo

Part 2

EXPERIMENTAL

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

Drug: CNTO 328 (Sp2/0-derived); Drug: CNTO 328 (CHO-derived)

Interventions

CNTO 328 (Sp2/0-derived) 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.

Also known as: SILTUXIMAB

Part 1; Part 2

CNTO 328 (CHO-derived) 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.

Also known as: SILTUXIMAB

Part 1; Part 2

Placebo DRUG

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

Part 1

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centocor, Inc.: lead

Study Sites (2)

Unknown Facility

Lincoln, Nebraska, United States

Location

Unknown Facility

Neptune City, New Jersey, United States

Location

MeSH Terms

Interventions

siltuximab

Study Officials

• Centocor Clinical Trial

  Centocor, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: February 28, 2014
• Study Start: June 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: February 5, 2015

Record last verified: 2015-02

Locations

US (2)