Status:
COMPLETED
A Study of JNJ-64281802 in Healthy Adult Participants
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-64281802 in healthy participants when administered in different multiple dose regimens and as different dose strengths.
Eligibility Criteria
Inclusion
- Healthy on the basis of physical examination, medical history (at screening only), and vital signs performed at screening and Day -1. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant or to be appropriate and reasonable for the population under study
- Body weight not less than 50 kilogram (kg) and body mass index (BMI) within the range 18.0 and 30.0 kilogram per meter square (kg/m\^2), extremes included, at screening and Day -1
- All women must have a negative highly sensitive serum (beta human chorionic gonadotropin \[beta hCG\]) at screening and a negative urine pregnancy test at Day -1
- Contraceptive use should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies
- Must sign an informed consent form (ICF) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study, before starting any screening activities
Exclusion
- Any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria
- Known allergies, hypersensitivity, or intolerance to JNJ-64281802 or its excipients
- Has been dosed with JNJ-64281802 in past 3 months
- Current human immunodeficiency virus type 1 (HIV-1) or type 2 (HIV-2) infection (confirmed by antibodies) at screening
- Current Coronavirus disease 2019 (COVID-19) infection (confirmed by severe acute respiratory syndrome coronavirus 2 \[SARS-CoV2\] polymerase chain reaction \[PCR\]) at the time of admission to the study site (Day -1)
Key Trial Info
Start Date :
February 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2022
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT05201937
Start Date
February 23 2022
End Date
December 11 2022
Last Update
March 30 2025
Active Locations (1)
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1
PRA Health Sciences Onderzoekscentrum Groningen, locatie Martini
Groningen, Netherlands, 9728 NZ