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A Safety and Pharmacokinetics Study of CNTO 3157 in Healthy Japanese and Caucasian Participants

NCT02008279 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-09-30

No results posted yet for this study

Summary

The purpose of this study is to find out if different doses of CNTO 3157 are well tolerated in both Japanese and Caucasian men as well as to understand how the body absorbs and removes the study drug after being injected or infused into the body.

Conditions

  • Healthy

Interventions

BIOLOGICAL

100 mg CNTO 3157

A single subcutaneous (SC) (under the skin) injection of 100 mg CNTO 3157

BIOLOGICAL

300 mg CNTO 3157

2 SC injections of CNTO 3157 providing a total dose of 300 mg

BIOLOGICAL

600 mg CNTO 3157

4 SC injections of CNTO 3157 providing a total dose of 600 mg

BIOLOGICAL

300 mg CNTO 3157

300 mg of CNTO 3157 as an intravenous (IV) infusion (into a vein) administered over a period of 30 minutes

DRUG

Placebo

SC injections of placebo (number of injections to equal number of injections of CNTO 3157)

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02008279 on ClinicalTrials.gov