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A Study to Assess the Safety, Pharmacokinetics and Immunogenicity of CR8020 in Japanese Healthy Participants

NCT02015533 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2019-03-25

No results posted yet for this study

Summary

The purpose of the study is to assess the safety, pharmacokinetics (what the body does to the drug) and immunogenicity (ability of a particular substance to provoke an immune response in the human body) of CR8020 in japanese healthy participants

Conditions

  • Healthy

Interventions

DRUG

CR8020

CR8020 50 mg/kg solution will be administered as a single 2-hour intravenous infusion.

DRUG

Placebo

Placebo will be administered as a single 2-hour intravenous infusion.

Sponsors & Collaborators

  • Janssen Pharmaceutical K.K.

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutical K.K., Japan Clinical Trial · Janssen Pharmaceutical K.K.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-01-31
Completion
2014-04-30

Countries

  • Japan

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 NCT02015533 on ClinicalTrials.gov