NCT02074800

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

A Phase 1, Randomized Study to Assess the Safety and Pharmacokinetics of a Single Intravenous Administration of CNTO 328 Derived From 2 Different Cell Lines in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Centocor, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	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.
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.
DRUG	Placebo	Participants will receive a single-dose of matching placebo intravenously in Part 1.

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2014-02-28
• Last updated: 2015-02-05

Locations

2 sites across 1 country: United States