A Study Evaluating Intravenous and Subcutaneous Administration of a Human Monoclonal Antibody (CNTO 5825) in Healthy Volunteers
September 30, 2010 updated by: Centocor, Inc.
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
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
64
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 001
CNTO 5825 0.1 mg/kg single dose Intravenously (IV) or matching placebo
|
10 mg/kg single dose IV or matching placebo
3 mg/kg single dose IV or matching placebo
For atopic patient:10 mg/kg single IV dose or matching placebo
For atopic patient: 3 mg/kg single dose SC or matching placebo
0.3 mg/kg single dose IV or matching placebo
0.1 mg/kg single dose Intravenously (IV) or matching placebo
1 mg/kg single dose IV or matching placebo
|
|
Experimental: 002
CNTO 5825 0.3 mg/kg single dose IV or matching placebo
|
10 mg/kg single dose IV or matching placebo
3 mg/kg single dose IV or matching placebo
For atopic patient:10 mg/kg single IV dose or matching placebo
For atopic patient: 3 mg/kg single dose SC or matching placebo
0.3 mg/kg single dose IV or matching placebo
0.1 mg/kg single dose Intravenously (IV) or matching placebo
1 mg/kg single dose IV or matching placebo
|
|
Experimental: 003
CNTO 5825 1 mg/kg single dose IV or matching placebo
|
10 mg/kg single dose IV or matching placebo
3 mg/kg single dose IV or matching placebo
For atopic patient:10 mg/kg single IV dose or matching placebo
For atopic patient: 3 mg/kg single dose SC or matching placebo
0.3 mg/kg single dose IV or matching placebo
0.1 mg/kg single dose Intravenously (IV) or matching placebo
1 mg/kg single dose IV or matching placebo
|
|
Experimental: 004
CNTO 5825 3 mg/kg single dose IV or matching placebo
|
10 mg/kg single dose IV or matching placebo
3 mg/kg single dose IV or matching placebo
For atopic patient:10 mg/kg single IV dose or matching placebo
For atopic patient: 3 mg/kg single dose SC or matching placebo
0.3 mg/kg single dose IV or matching placebo
0.1 mg/kg single dose Intravenously (IV) or matching placebo
1 mg/kg single dose IV or matching placebo
|
|
Experimental: 005
CNTO 5825 10 mg/kg single dose IV or matching placebo
|
10 mg/kg single dose IV or matching placebo
3 mg/kg single dose IV or matching placebo
For atopic patient:10 mg/kg single IV dose or matching placebo
For atopic patient: 3 mg/kg single dose SC or matching placebo
0.3 mg/kg single dose IV or matching placebo
0.1 mg/kg single dose Intravenously (IV) or matching placebo
1 mg/kg single dose IV or matching placebo
|
|
Experimental: 006
CNTO 5825 For atopic patient:10 mg/kg single IV dose or matching placebo
|
10 mg/kg single dose IV or matching placebo
3 mg/kg single dose IV or matching placebo
For atopic patient:10 mg/kg single IV dose or matching placebo
For atopic patient: 3 mg/kg single dose SC or matching placebo
0.3 mg/kg single dose IV or matching placebo
0.1 mg/kg single dose Intravenously (IV) or matching placebo
1 mg/kg single dose IV or matching placebo
|
|
Experimental: 007
CNTO 5825 For atopic patient: 3 mg/kg single dose SC or matching placebo
|
10 mg/kg single dose IV or matching placebo
3 mg/kg single dose IV or matching placebo
For atopic patient:10 mg/kg single IV dose or matching placebo
For atopic patient: 3 mg/kg single dose SC or matching placebo
0.3 mg/kg single dose IV or matching placebo
0.1 mg/kg single dose Intravenously (IV) or matching placebo
1 mg/kg single dose IV or matching placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
Time Frame: 17 weeks post dose
|
17 weeks post dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Evaluate the effects of CNTO5825 on the body and the effects of the body on CNTO 5825 (Pharmacokinetics (PK), Pharmacodynamics (PD))
Time Frame: 17 weeks post dose
|
17 weeks post dose
|
|
Immune response (Immunogenicity) after dose with CNTO 5825
Time Frame: 17 weeks post dose
|
17 weeks post dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion
December 7, 2022
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
February 18, 2010
First Submitted That Met QC Criteria
March 4, 2010
First Posted (Estimate)
March 5, 2010
Study Record Updates
Last Update Posted (Estimate)
October 1, 2010
Last Update Submitted That Met QC Criteria
September 30, 2010
Last Verified
September 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR015574
- EudraCT No.: 2009-013343-11
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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