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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 001
CNTO 5825 0.1 mg/kg single dose Intravenously (IV) or matching placebo
Biological: CNTO 5825
10 mg/kg single dose IV or matching placebo
Biological: CNTO 5825
3 mg/kg single dose IV or matching placebo
Biological: CNTO 5825
For atopic patient:10 mg/kg single IV dose or matching placebo
Biological: CNTO 5825
For atopic patient: 3 mg/kg single dose SC or matching placebo
Biological: CNTO 5825
0.3 mg/kg single dose IV or matching placebo
Biological: CNTO 5825
0.1 mg/kg single dose Intravenously (IV) or matching placebo
Biological: CNTO 5825
1 mg/kg single dose IV or matching placebo
Experimental: 002
CNTO 5825 0.3 mg/kg single dose IV or matching placebo
Biological: CNTO 5825
10 mg/kg single dose IV or matching placebo
Biological: CNTO 5825
3 mg/kg single dose IV or matching placebo
Biological: CNTO 5825
For atopic patient:10 mg/kg single IV dose or matching placebo
Biological: CNTO 5825
For atopic patient: 3 mg/kg single dose SC or matching placebo
Biological: CNTO 5825
0.3 mg/kg single dose IV or matching placebo
Biological: CNTO 5825
0.1 mg/kg single dose Intravenously (IV) or matching placebo
Biological: CNTO 5825
1 mg/kg single dose IV or matching placebo
Experimental: 003
CNTO 5825 1 mg/kg single dose IV or matching placebo
Biological: CNTO 5825
10 mg/kg single dose IV or matching placebo
Biological: CNTO 5825
3 mg/kg single dose IV or matching placebo
Biological: CNTO 5825
For atopic patient:10 mg/kg single IV dose or matching placebo
Biological: CNTO 5825
For atopic patient: 3 mg/kg single dose SC or matching placebo
Biological: CNTO 5825
0.3 mg/kg single dose IV or matching placebo
Biological: CNTO 5825
0.1 mg/kg single dose Intravenously (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
10 mg/kg single dose IV or matching placebo
Biological: CNTO 5825
3 mg/kg single dose IV or matching placebo
Biological: CNTO 5825
For atopic patient:10 mg/kg single IV dose or matching placebo
Biological: CNTO 5825
For atopic patient: 3 mg/kg single dose SC or matching placebo
Biological: CNTO 5825
0.3 mg/kg single dose IV or matching placebo
Biological: CNTO 5825
0.1 mg/kg single dose Intravenously (IV) or matching placebo
Biological: CNTO 5825
1 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
Biological: CNTO 5825
3 mg/kg single dose IV or matching placebo
Biological: CNTO 5825
For atopic patient:10 mg/kg single IV dose or matching placebo
Biological: CNTO 5825
For atopic patient: 3 mg/kg single dose SC or matching placebo
Biological: CNTO 5825
0.3 mg/kg single dose IV or matching placebo
Biological: CNTO 5825
0.1 mg/kg single dose Intravenously (IV) or matching placebo
Biological: CNTO 5825
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
Biological: CNTO 5825
10 mg/kg single dose IV or matching placebo
Biological: CNTO 5825
3 mg/kg single dose IV or matching placebo
Biological: CNTO 5825
For atopic patient:10 mg/kg single IV dose or matching placebo
Biological: CNTO 5825
For atopic patient: 3 mg/kg single dose SC or matching placebo
Biological: CNTO 5825
0.3 mg/kg single dose IV or matching placebo
Biological: CNTO 5825
0.1 mg/kg single dose Intravenously (IV) or matching placebo
Biological: CNTO 5825
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
Biological: CNTO 5825
10 mg/kg single dose IV or matching placebo
Biological: CNTO 5825
3 mg/kg single dose IV or matching placebo
Biological: CNTO 5825
For atopic patient:10 mg/kg single IV dose or matching placebo
Biological: CNTO 5825
For atopic patient: 3 mg/kg single dose SC or matching placebo
Biological: CNTO 5825
0.3 mg/kg single dose IV or matching placebo
Biological: CNTO 5825
0.1 mg/kg single dose Intravenously (IV) or matching placebo
Biological: CNTO 5825
1 mg/kg single dose IV or matching placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centocor, Inc.

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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2010

Primary Completion

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 7, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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