A Study of JNJ-73763989 in Healthy Japanese Adult Participants

A Double-blind, Placebo-controlled, Randomized, Parallel, Single Dose Study to Investigate Pharmacokinetics, Safety, and Tolerability of JNJ-73763989 in Healthy Japanese Adult Participants

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).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: JNJ-73763989; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, HA1 3UJ
    • PAREXEL International

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Panel A: JNJ-73763989 or Placebo; Participants will receive JNJ-73763989 (Dose Level 1) or matching placebo as single subcutaneous injection.	Drug: JNJ-73763989; Participants will receive JNJ-73763989 as single subcutaneous injection.; Drug: Placebo; Participants will receive placebo matching to JNJ-73763989 as single subcutaneous injection.
Experimental: Panel B: JNJ-73763989 or Placebo; Participants will receive JNJ-73763989 (Dose Level 2) or matching placebo as single subcutaneous injection.	Drug: JNJ-73763989; Participants will receive JNJ-73763989 as single subcutaneous injection.; Drug: Placebo; Participants will receive placebo matching to JNJ-73763989 as single subcutaneous injection.
Experimental: Panel C: JNJ-73763989 or Placebo; Participants will receive JNJ-73763989 (Dose Level 3) or matching placebo as single subcutaneous injection.	Drug: JNJ-73763989; Participants will receive JNJ-73763989 as single subcutaneous injection.; Drug: Placebo; Participants will receive placebo matching to JNJ-73763989 as single subcutaneous injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Janssen Sciences Ireland UC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2019
• Primary Completion (Actual): August 23, 2019
• Study Completion (Actual): August 23, 2019

Study Registration Dates

• First Submitted: June 27, 2019
• First Submitted That Met QC Criteria: June 27, 2019
• First Posted (Actual): July 1, 2019

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 25, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CR108646; 2019-000629-31 (EudraCT Number); 73763989HPB1001 (Other Identifier: Janssen Sciences Ireland UC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes