Healthy
Conditions
Brief summary
The purpose of this study is to investigate the pharmacokinetics, safety, and tolerability of JNJ-73763989 in healthy Japanese adult participants following single-dose subcutaneous administration of 3 different doses of JNJ-73763989, Dose Level 1 (Panel A), Dose Level 2 (Panel B) or Dose Level 3 (Panel C).
Interventions
DRUGJNJ-73763989
Participants will receive JNJ-73763989 as single subcutaneous injection.
DRUGPlacebo
Participants will receive placebo matching to JNJ-73763989 as single subcutaneous injection.
Sponsors
Janssen Sciences Ireland UC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant must be a Japanese participant who has resided outside Japan for no more than 10 years and whose parents and grandparents are Japanese, as determined by participant's verbal report * Participant must have a body mass index (BMI; weight in kilogram \[kg\] divided by the square of height in meters) of 18.0 to 30.0 kilogram per square meter (kg/m\^2) extremes included, and body weight not less than 45.0 kg * Participant must be healthy on the basis of physical examination, clinical laboratory tests, medical history, and vital signs performed at screening. In case of abnormalities (except for those listed in the
Exclusion criteria
) a participant may be included after all if the investigator judges the abnormalities not clinically significant or appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator * A female participant of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and a negative urine pregnancy test on Day -1 * A male participant must agree not to donate sperm after enrollment (Day 1) in the study until at least 90 days after receiving the study drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 | Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose | Cmax is the maximum observed plasma analyte concentration. |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 | Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose | Tmax is defined as actual sampling time to reach maximum observed plasma analyte concentration. |
| Last Measurable Observed Plasma Concentration (Clast) of JNJ-73763989 | Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose | Clast is last measurable observed plasma analyte concentration. |
| Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Measurable Concentration (AUC[0-last]) of JNJ-73763989 | Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose | AUC(0-last) is area under the plasma concentration-time curve from time zero to the time of the last measurable (non-below quantification limit \[non-BQL\]) concentration, calculated by linear-linear trapezoidal summation. |
| Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability | Up to 30 days after last study drug administration (Up to 7 weeks) | AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. |
Countries
United Kingdom
Outcome results
None listed