A Study Evaluating Intravenous and Subcutaneous Administration of a Human Monoclonal Antibody (CNTO 5825) in Healthy Volunteers

Sponsor

Centocor, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01081691

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and tolerability of CNTO 5825 following a single intravenous (IV) or subcutaneous (SC) dose administration in healthy volunteers.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Biological: CNTO 5825 Biological: CNTO 5825 Biological: CNTO 5825 Biological: CNTO 5825 Biological: CNTO 5825 Biological: CNTO 5825 Biological: CNTO 5825	Phase 1

Detailed Description

This is a randomized (study medication assigned by chance), placebo controlled, double-blind (neither physician or subject knows the name of the assigned study medication) study to assess the safety, tolerability, immune response, pharmacokinetics (what the body does to the drug), and pharmacodynamics (what the drug does to the body) of CNTO 5825. The study population will consist of 48 healthy volunteers and 16 healthy atopic volunteers. Five dose levels of study agent will be assessed. Participants will be required to stay at the research center after study agent administration for the inpatient portion of the study and then return for out-patient visits. Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events. Placebo (containing inactive substances only) or one of five dose levels of CNTO 5825 will be given. Healthy volunteers will be given a single IV infusion (directly into a vein) or a single dose of up to 3 injections under the skin. Healthy atopic volunteers will be given one dose as as an IV infusion. There will be a screening period of up to 4 weeks. All participants will be in the study for 17 weeks after dose administration.

Study Design

Study Type:

Interventional

Actual Enrollment :

64 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-blind, Placebo-controlled, Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CNTO 5825 Following a Single Intravenous or a Single Subcutaneous Administration in Healthy Subjects

Study Start Date :

Feb 1, 2010

Actual Study Completion Date :

Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 001 CNTO 5825 0.1 mg/kg single dose Intravenously (IV) or matching placebo	Biological: CNTO 5825 0.1 mg/kg single dose Intravenously (IV) or matching placebo
Experimental: 002 CNTO 5825 0.3 mg/kg single dose IV or matching placebo	Biological: CNTO 5825 0.3 mg/kg single dose IV or matching placebo
Experimental: 003 CNTO 5825 1 mg/kg single dose IV or matching placebo	Biological: CNTO 5825 1 mg/kg single dose IV or matching placebo
Experimental: 004 CNTO 5825 3 mg/kg single dose IV or matching placebo	Biological: CNTO 5825 3 mg/kg single dose IV or matching placebo
Experimental: 005 CNTO 5825 10 mg/kg single dose IV or matching placebo	Biological: CNTO 5825 10 mg/kg single dose IV or matching placebo
Experimental: 006 CNTO 5825 For atopic patient:10 mg/kg single IV dose or matching placebo	Biological: CNTO 5825 For atopic patient:10 mg/kg single IV dose or matching placebo
Experimental: 007 CNTO 5825 For atopic patient: 3 mg/kg single dose SC or matching placebo	Biological: CNTO 5825 For atopic patient: 3 mg/kg single dose SC or matching placebo

Outcome Measures

Primary Outcome Measures

Safety and tolerability of CNTO 5825 by evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events in healthy volunteers. [17 weeks post dose]

Secondary Outcome Measures

Evaluate the effects of CNTO5825 on the body and the effects of the body on CNTO 5825 (Pharmacokinetics (PK), Pharmacodynamics (PD)) [17 weeks post dose]
Immune response (Immunogenicity) after dose with CNTO 5825 [17 weeks post dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy man or woman with no clinically significant abnormalities
Body weight in the range of 50 to 100 kg inclusive
Body mass index (BMI) of 18.5 to 30 kg/m2 inclusive
For healthy atopic patients: history of atopic allergy

Exclusion Criteria:

Known or suspected intolerance or hypersensitivity to any biologic medication or to any components of the formulation used in this study
Received an experimental antibody or biologic therapy within the previous 6 months