A Phase 1 Study of CNTO 3157 in Healthy Volunteers and Patients With Asthma

November 22, 2012 updated by: Centocor, Inc.

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Intravenous Study in Healthy Subjects and a Multiple-Dose Intravenous Study in Asthmatic Subjects to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of CNTO 3157

This is a phase 1, safety study of CNTO 3157 in healthy subjects and subjects with asthma.

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

A phase 1, randomized (study drug assigned by chance), double blind (neither physician nor patient knows if CNTO 3157 or placebo has been assigned), placebo controlled, single, ascending-dose study of CNTO 3157 in healthy volunteers and multiple dose study in patients with asthma. This study will compare the effects (both good and bad) of CNTO 3157 to those of placebo. The purpose of this study is to evaluate the safety and potential side effects of CNTO 3157 given to healthy volunteers and patients with asthma. In addition, the investigators will measure how much study drug is in the blood following a dose of CNTO 3157, and determine if the body makes antibodies to it. (An antibody is a protein made by the body in response to a foreign substance). 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. There will be 2 parts to this study. The first part of this study will involve healthy volunteers, and the second part of the study will involve patients with asthma. About 56 healthy volunteers and 16 asthmatic patients will take part. Volunteers will be required to stay at the research center after study agent administration for an inpatient portion of the study and then return for required out-patient visits. Up to approximately 8 different dose levels will be studied. CNTO 3157 will be administered by IV infusion. The duration of volunteer participation will be up to 21 weeks in Part 1 and up to 24 weeks in Part 2.

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.
79

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male or female between 18 and 55 years of age inclusive with no clinically significant abnormalities and have a body weight of 50 to 100 kg
  • Patients with asthma must have been diagnosed at least 6 months prior to participation in the study

Exclusion Criteria:

  • Currently have or have a history of any clinically significant medical illness or medical disorders the investigator considers should exclude the subject, including (but not limited to) cardiovascular disease, neuromuscular, hematological disease, immune deficiency state, respiratory disease (other than asthma for Part 2), hepatic or GI disease, neurological or psychiatric disease, ophthalmological disorders, neoplastic disease, renal or urinary tract diseases, or dermatological disease
  • Have a positive pregnancy test at screening or prior to dose administration
  • Have smoked tobacco or related products within 6 months prior to dosing
  • Donated blood equal to or greater than ¿450 mL within 60 days prior to participation in the study
  • Recent history (within previous 6 months) of alcohol or drug abuse

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: Double

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 3157 or placebo 0.003 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.003 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.03 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
10 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.01 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
1 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
3 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.3 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.1 mg/kg CNTO 3157 or placebo infusion
Experimental: 002
CNTO 3157 or placebo 0.01 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.003 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.03 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
10 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.01 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
1 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
3 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.3 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.1 mg/kg CNTO 3157 or placebo infusion
Experimental: 003
CNTO 3157 or placebo 0.03 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.003 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.03 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
10 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.01 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
1 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
3 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.3 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.1 mg/kg CNTO 3157 or placebo infusion
Experimental: 004
CNTO 3157 or placebo 0.1 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.003 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.03 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
10 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.01 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
1 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
3 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.3 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.1 mg/kg CNTO 3157 or placebo infusion
Experimental: 005
CNTO 3157 or placebo 0.3 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.003 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.03 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
10 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.01 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
1 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
3 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.3 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.1 mg/kg CNTO 3157 or placebo infusion
Experimental: 006
CNTO 3157 or placebo 1 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.003 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.03 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
10 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.01 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
1 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
3 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.3 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.1 mg/kg CNTO 3157 or placebo infusion
Experimental: 007
CNTO 3157 or placebo 3 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.003 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.03 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
10 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.01 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
1 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
3 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.3 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.1 mg/kg CNTO 3157 or placebo infusion
Experimental: 008
CNTO 3157 or placebo 10 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.003 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.03 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
10 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.01 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
1 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
3 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.3 mg/kg CNTO 3157 or placebo infusion
Biological: CNTO 3157 or placebo
0.1 mg/kg CNTO 3157 or placebo infusion

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 3157 by evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events
Time Frame: Week 21 for Part 1 and Week 24 for Part 2
Week 21 for Part 1 and Week 24 for Part 2

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 CNTO3157 on the body and the effects of the body on CNTO 3157 (Pharmacokinetics (PK), Pharmacodynamics (PD))
Time Frame: Week 21 for Part 1 and Week 24 for Part 2
Week 21 for Part 1 and Week 24 for Part 2
Immune response (Immunogenicity)
Time Frame: Week 21 for Part 1 and Week 24 for Part 2
Week 21 for Part 1 and Week 24 for Part 2
Clinical Response
Time Frame: Week 21 for Part 1 and Week 24 for Part 2
Week 21 for Part 1 and Week 24 for Part 2

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.

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.
June 1, 2010

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.
January 1, 2012

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).
September 2, 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.
September 2, 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.
September 6, 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.
November 27, 2012

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.
November 22, 2012

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.
November 1, 2012

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.
  • CR017095

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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