MedTrace Logo

A Safety, Tolerability, Pharmacokinetics, and Immunogenicity Study of CNTO 6785 in Healthy Volunteers

NCT01288196 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2013-01-28

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, tolerability, blood levels, and immune responses of CNTO 6785 after administration to healthy adult volunteers.

Conditions

  • Healthy

Interventions

DRUG

Placebo IV

A single 30-minute IV infusion of placebo

DRUG

CNTO 6785 1 mg/kg IV

A single 30-minute IV infusion of CNTO 6785 1 mg/kg

DRUG

CNTO 6785 3 mg/kg IV

A single 30-minute IV infusion of CNTO 6785 3 mg/kg

DRUG

CNTO 6785 10 mg/kg IV

A single 30-minute IV infusion of CNTO 6785 10 mg/kg

DRUG

CNTO 6785 SC

A single SC dose of CNTO 6785 (3 mg/kg) administered in up to 3 SC injections

DRUG

Placebo SC

A single SC dose of placebo administered in up to 3 SC injections

Sponsors & Collaborators

  • Janssen-Cilag International NV

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag International NV Clinical Trial · Janssen-Cilag International NV

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
2011-02-28
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • Belgium

Study Locations

More Related Trials

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 NCT01288196 on ClinicalTrials.gov