Status:
COMPLETED
A Study of JNJ-64300535 in Healthy Participants
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the cellular immunogenicity of 3 monthly electroporation-mediated intramuscular (IM) injections of JNJ-64300535 in healthy participants.
Eligibility Criteria
Inclusion
- Must sign an informed consent form (ICF) indicating that he understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study
- Willing and able to adhere to the prohibitions and restrictions specified in this protocol
- Must be healthy as confirmed by medical history, physical examination, and vital signs performed at screening
Exclusion
- Weight of less than (\<) 50 kilograms (kg) and a body mass index (BMI) \<19.0 or greater than (\>) 29.9 kilogram per meter square (kg/m\^2) at screening
- History of Human Immunodeficiency Virus (HIV) infection or a positive HIV antibody test at screening
- History of HBV infection, measured by the presence of HBsAg and/or anti-HBc antibodies
- History of seizure disorders unless seizure free for \>5 years
- Has a non-removable active electronic stimulation device
Key Trial Info
Start Date :
February 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2021
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04736147
Start Date
February 3 2021
End Date
December 7 2021
Last Update
December 22 2021
Active Locations (1)
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1
SGS Belgium NV
Edegem, Belgium, 2650