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

NCT ID: NCT01195207

Last Updated: 2012-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Asthma

Keywords

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CNTO 3157 healthy volunteers asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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001

CNTO 3157 or placebo 0.003 mg/kg CNTO 3157 or placebo infusion

Group Type EXPERIMENTAL

CNTO 3157 or placebo

Intervention Type BIOLOGICAL

0.003 mg/kg CNTO 3157 or placebo infusion

002

CNTO 3157 or placebo 0.01 mg/kg CNTO 3157 or placebo infusion

Group Type EXPERIMENTAL

CNTO 3157 or placebo

Intervention Type BIOLOGICAL

0.01 mg/kg CNTO 3157 or placebo infusion

003

CNTO 3157 or placebo 0.03 mg/kg CNTO 3157 or placebo infusion

Group Type EXPERIMENTAL

CNTO 3157 or placebo

Intervention Type BIOLOGICAL

0.03 mg/kg CNTO 3157 or placebo infusion

004

CNTO 3157 or placebo 0.1 mg/kg CNTO 3157 or placebo infusion

Group Type EXPERIMENTAL

CNTO 3157 or placebo

Intervention Type BIOLOGICAL

0.1 mg/kg CNTO 3157 or placebo infusion

005

CNTO 3157 or placebo 0.3 mg/kg CNTO 3157 or placebo infusion

Group Type EXPERIMENTAL

CNTO 3157 or placebo

Intervention Type BIOLOGICAL

0.3 mg/kg CNTO 3157 or placebo infusion

006

CNTO 3157 or placebo 1 mg/kg CNTO 3157 or placebo infusion

Group Type EXPERIMENTAL

CNTO 3157 or placebo

Intervention Type BIOLOGICAL

1 mg/kg CNTO 3157 or placebo infusion

007

CNTO 3157 or placebo 3 mg/kg CNTO 3157 or placebo infusion

Group Type EXPERIMENTAL

CNTO 3157 or placebo

Intervention Type BIOLOGICAL

3 mg/kg CNTO 3157 or placebo infusion

008

CNTO 3157 or placebo 10 mg/kg CNTO 3157 or placebo infusion

Group Type EXPERIMENTAL

CNTO 3157 or placebo

Intervention Type BIOLOGICAL

10 mg/kg CNTO 3157 or placebo infusion

Interventions

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CNTO 3157 or placebo

0.003 mg/kg CNTO 3157 or placebo infusion

Intervention Type BIOLOGICAL

CNTO 3157 or placebo

0.03 mg/kg CNTO 3157 or placebo infusion

Intervention Type BIOLOGICAL

CNTO 3157 or placebo

10 mg/kg CNTO 3157 or placebo infusion

Intervention Type BIOLOGICAL

CNTO 3157 or placebo

0.01 mg/kg CNTO 3157 or placebo infusion

Intervention Type BIOLOGICAL

CNTO 3157 or placebo

1 mg/kg CNTO 3157 or placebo infusion

Intervention Type BIOLOGICAL

CNTO 3157 or placebo

3 mg/kg CNTO 3157 or placebo infusion

Intervention Type BIOLOGICAL

CNTO 3157 or placebo

0.3 mg/kg CNTO 3157 or placebo infusion

Intervention Type BIOLOGICAL

CNTO 3157 or placebo

0.1 mg/kg CNTO 3157 or placebo infusion

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centocor, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Centocor, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Centocor, Inc.

Locations

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Antwerp, , Belgium

Site Status

Merksem, , Belgium

Site Status

Berlin, , Germany

Site Status

Harrow, , United Kingdom

Site Status

Countries

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Belgium Germany United Kingdom

Other Identifiers

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CR017095

Identifier Type: -

Identifier Source: org_study_id