Clinical trial NCT04002752: A Study of JNJ-73763989 in Healthy Japanese Adult Participants
Official title: A Double-blind, Placebo-controlled, Randomized, Parallel, Single Dose Study to Investigate Pharmacokinetics, Safety, and Tolerability of JNJ-73763989 in Healthy Japanese Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Sciences Ireland UC
Sponsor class: INDUSTRY
First posted: 2019-07-01
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).


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

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989
timeFrame: Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989
timeFrame: Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose
measure: Last Measurable Observed Plasma Concentration (Clast) of JNJ-73763989
timeFrame: Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose
measure: Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Measurable Concentration (AUC[0-last]) of JNJ-73763989
timeFrame: Predose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours postdose
measure: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
timeFrame: Up to 30 days after last study drug administration (Up to 7 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: PAREXEL International
Study officials:
affiliation: Janssen Sciences Ireland UC
name: Janssen Sciences Ireland UC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.