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

NCT ID: NCT01081691

Last Updated: 2010-10-01

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

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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001

CNTO 5825 0.1 mg/kg single dose Intravenously (IV) or matching placebo

Group Type EXPERIMENTAL

CNTO 5825

Intervention Type BIOLOGICAL

0.1 mg/kg single dose Intravenously (IV) or matching placebo

002

CNTO 5825 0.3 mg/kg single dose IV or matching placebo

Group Type EXPERIMENTAL

CNTO 5825

Intervention Type BIOLOGICAL

0.3 mg/kg single dose IV or matching placebo

003

CNTO 5825 1 mg/kg single dose IV or matching placebo

Group Type EXPERIMENTAL

CNTO 5825

Intervention Type BIOLOGICAL

1 mg/kg single dose IV or matching placebo

004

CNTO 5825 3 mg/kg single dose IV or matching placebo

Group Type EXPERIMENTAL

CNTO 5825

Intervention Type BIOLOGICAL

3 mg/kg single dose IV or matching placebo

005

CNTO 5825 10 mg/kg single dose IV or matching placebo

Group Type EXPERIMENTAL

CNTO 5825

Intervention Type BIOLOGICAL

10 mg/kg single dose IV or matching placebo

006

CNTO 5825 For atopic patient:10 mg/kg single IV dose or matching placebo

Group Type EXPERIMENTAL

CNTO 5825

Intervention Type BIOLOGICAL

For atopic patient:10 mg/kg single IV dose or matching placebo

007

CNTO 5825 For atopic patient: 3 mg/kg single dose SC or matching placebo

Group Type EXPERIMENTAL

CNTO 5825

Intervention Type BIOLOGICAL

For atopic patient: 3 mg/kg single dose SC or matching placebo

Interventions

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CNTO 5825

10 mg/kg single dose IV or matching placebo

Intervention Type BIOLOGICAL

CNTO 5825

3 mg/kg single dose IV or matching placebo

Intervention Type BIOLOGICAL

CNTO 5825

For atopic patient:10 mg/kg single IV dose or matching placebo

Intervention Type BIOLOGICAL

CNTO 5825

For atopic patient: 3 mg/kg single dose SC or matching placebo

Intervention Type BIOLOGICAL

CNTO 5825

0.3 mg/kg single dose IV or matching placebo

Intervention Type BIOLOGICAL

CNTO 5825

0.1 mg/kg single dose Intravenously (IV) or matching placebo

Intervention Type BIOLOGICAL

CNTO 5825

1 mg/kg single dose IV or matching placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
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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Centocor

Principal Investigators

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Centocor, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Centocor, Inc.

References

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van Hartingsveldt B, Nnane IP, Bouman-Thio E, Loza MJ, Piantone A, Davis HM, Petty KJ. Safety, tolerability and pharmacokinetics of a human anti-interleukin-13 monoclonal antibody (CNTO 5825) in an ascending single-dose first-in-human study. Br J Clin Pharmacol. 2013 May;75(5):1289-98. doi: 10.1111/j.1365-2125.2012.04477.x.

Reference Type DERIVED
PMID: 23043368 (View on PubMed)

Other Identifiers

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EudraCT No.: 2009-013343-11

Identifier Type: -

Identifier Source: secondary_id

CR015574

Identifier Type: -

Identifier Source: org_study_id