A Study of JNJ-73763989 in Healthy Japanese Adult Partici... | NCT04002752

NCT04002752

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2019-000629-31	EudraCT Number
73763989HPB1001	Other Identifier	Janssen Sciences Ireland UC

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Panel A: JNJ-73763989 or Placebo	Experimental	Participants will receive JNJ-73763989 (Dose Level 1) or matching placebo as single subcutaneous injection.	Drug: JNJ-73763989 Drug: Placebo
Panel B: JNJ-73763989 or Placebo	Experimental	Participants will receive JNJ-73763989 (Dose Level 2) or matching placebo as single subcutaneous injection.	Drug: JNJ-73763989 Drug: Placebo
Panel C: JNJ-73763989 or Placebo	Experimental	Participants will receive JNJ-73763989 (Dose Level 3) or matching placebo as single subcutaneous injection.	Drug: JNJ-73763989 Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JNJ-73763989	Drug	Participants will receive JNJ-73763989 as single subcutaneous injection.	Panel A: JNJ-73763989 or Placebo Panel B: JNJ-73763989 or Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989	Cmax is the maximum observed plasma analyte concentration.	Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989	Tmax is defined as actual sampling time to reach maximum observed plasma analyte concentration.	Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose
Last Measurable Observed Plasma Concentration (Clast) of JNJ-73763989	Clast is last measurable observed plasma analyte concentration.	Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose
Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Measurable Concentration (AUC[0-last]) of JNJ-73763989	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.	Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose
Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability	AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.	Up to 30 days after last study drug administration (Up to 7 weeks)

Eligibility Module

Eligibility Criteria

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

Exclusion Criteria:

Participant with a history of cardiac arrhythmias (for example, premature ventricular contractions), history of risk factors for Torsade de Pointes syndrome (for example, hypokalemia, family history of long QT Syndrome)
Female participant who is pregnant, breast-feeding, or planning to become pregnant during the study or within 90 days after receiving the study drug (or longer, if dictated by local regulation)
Male participants who plan to father a child during the study or within 90 days after receiving the study drug (or longer, if dictated by local regulation)
Participant with human immunodeficiency virus type 1 (HIV-1) or type 2 (HIV-2) infection (confirmed by antibodies) at screening
Participant with current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin M [IgM]), or hepatitis B infection (confirmed by Hepatitis B surface antigen [HBsAg]), or hepatitis C virus (HCV) infection (confirmed by HCV antibody), or hepatitis E infection (confirmed by hepatitis E antibody IgM) at screening

Name	Affiliation	Role
Janssen Sciences Ireland UC Clinical Trial	Janssen Sciences Ireland UC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
PAREXEL International		London		HA1 3UJ	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35695169	Derived	Gane E, Yuen MF, Kakuda TN, Ogawa T, Takahashi Y, Goeyvaerts N, Lonjon-Domanec I, Vaughan T, Schluep T, Hamilton J, Njumbe Ediage E, Hillewaert V, Snoeys J, Lenz O, Talloen W, Biermer M. JNJ-73763989 pharmacokinetics and safety: Liver-targeted siRNAs against hepatitis B virus, in Japanese and non-Japanese healthy adults, and combined with JNJ-56136379 and a nucleos(t)ide analogue in patients with chronic hepatitis B. Antivir Ther. 2022 Jun;27(3):13596535221093856. doi: 10.1177/13596535221093856.

IPD Sharing Statement Module