Status:
COMPLETED
To Assess the Pharmacokinetics and Safety of Single Doses of JNJ-54452840 in Healthy Japanese and Caucasian Participants
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Healthy
Eligibility:
MALE
20-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and safety of JNJ-54452840 in healthy participants.
Detailed Description
This is a Phase 1, randomized (the study treatment is assigned by chance), double-blind (neither physician nor participant knows the treatment received), placebo-controlled (one of the study treatment...
Eligibility Criteria
Inclusion
- Must be a healthy male with no clinically relevant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments - Must be Japanese or Caucasian
- Japanese participants must have been born in Japan, have resided outside of Japan for no more than 5 years, and have Japanese parents and maternal and paternal grandparents
- Caucasian participants must have Caucasian parents
Exclusion
- History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Have a known or suspected intolerance or hypersensitivity to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human peptides or protein
- Be unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01809353
Start Date
July 1 2013
End Date
September 1 2014
Last Update
March 23 2015
Active Locations (1)
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1
Cypress, California, United States