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

NCT01081691 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2010-10-01

No results posted yet for this study

Summary

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.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Centocor, Inc.

    lead INDUSTRY

Principal Investigators

  • Centocor, Inc. Clinical Trial · Centocor, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-28
Completion
2010-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01081691 on ClinicalTrials.gov