A Study of JNJ-64281802 in Healthy Adult Participants
Status and phase
Completed
Phase 1
Conditions
Healthy
Treatments
Drug: JNJ-64281802
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
33 patients
Sex
All
Ages
18 to 55 years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- 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 criteria
- 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)
Trial design
Primary purpose
Basic Science
Allocation
Non-Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
33 participants in 6 patient groups
Arm A: Panel 1 (JNJ-64281802 High Dose Regimen)
Experimental group
Description:
Participants will receive Loading Dose (LD) 1 of JNJ-64281802 twice daily on Days 1 and 2 followed by maintenance Dose (MD) 1 of JNJ-64281802 once daily on Days 3, 10, 17 and 24.
Treatment:
Drug: JNJ-64281802
Arm A: Panel 2 (JNJ-64281802 High Dose Regimen)
Experimental group
Description:
Participants will receive LD 1 of JNJ-64281802 twice daily on Days 1 and 2 followed by MD 2 of JNJ-64281802 once daily on Days 3, 6, 10, 13, 17, 20, 24, and 27.
Treatment:
Drug: JNJ-64281802
Arm B: Panel 3 (JNJ-64281802 Low Dose Regimen)
Experimental group
Description:
Participants will receive LD 2 of JNJ-64281802 twice daily on Days 1 and 2 followed by MD 3 of JNJ-64281802 once daily on Days 3, 10, 17 and 24.
Treatment:
Drug: JNJ-64281802
Arm B: Panel 4 (JNJ-64281802 Low Dose Regimen)
Experimental group
Description:
Participants will receive LD 2 of JNJ-64281802 twice daily on Days 1 and 2 followed by MD 4 of JNJ-64281802 once daily on Days 3, 6, 10, 13, 17, 20, 24, and 27.
Treatment:
Drug: JNJ-64281802
Arm C: Panel 5 (JNJ-64281802 [Optional])
Experimental group
Description:
Participants dosing regimen(s) will be determined based on the results of Study Arm A and Study Arm B.
Treatment:
Drug: JNJ-64281802
Arm C: Panel 6 (JNJ-64281802 [Optional])
Experimental group
Description:
Participants dosing regimen(s) will be determined based on the results of Study Arm A and Study Arm B.
Treatment:
Drug: JNJ-64281802
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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