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

Study Overview
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Biological: CNTO 5825
* Biological: CNTO 5825
* Biological: CNTO 5825
* Biological: CNTO 5825
* Biological: CNTO 5825
* Biological: CNTO 5825
* Biological: CNTO 5825


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 001<br>CNTO 5825 0.1 mg/kg single dose Intravenously (IV) or matching placebo | Biological: CNTO 5825<br>* 0.1 mg/kg single dose Intravenously (IV) or matching placebo<br>|
| Experimental: 002<br>CNTO 5825 0.3 mg/kg single dose IV or matching placebo | Biological: CNTO 5825<br>* 0.3 mg/kg single dose IV or matching placebo<br>|
| Experimental: 003<br>CNTO 5825 1 mg/kg single dose IV or matching placebo | Biological: CNTO 5825<br>* 1 mg/kg single dose IV or matching placebo<br>|
| Experimental: 004<br>CNTO 5825 3 mg/kg single dose IV or matching placebo | Biological: CNTO 5825<br>* 3 mg/kg single dose IV or matching placebo<br>|
| Experimental: 005<br>CNTO 5825 10 mg/kg single dose IV or matching placebo | Biological: CNTO 5825<br>* 10 mg/kg single dose IV or matching placebo<br>|
| Experimental: 006<br>CNTO 5825 For atopic patient:10 mg/kg single IV dose or matching placebo | Biological: CNTO 5825<br>* For atopic patient:10 mg/kg single IV dose or matching placebo<br>|
| Experimental: 007<br>CNTO 5825 For atopic patient: 3 mg/kg single dose SC or matching placebo | Biological: CNTO 5825<br>* For atopic patient: 3 mg/kg single dose SC or matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 17 weeks post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effects of CNTO5825 on the body and the effects of the body on CNTO 5825 (Pharmacokinetics (PK), Pharmacodynamics (PD)) |  | 17 weeks post dose | 
| Immune response (Immunogenicity) after dose with CNTO 5825 |  | 17 weeks post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CNTO 5825, Safety, Phase I, Healthy adults, Healthy Atopic adults