A Study of JNJ-73763989 in Healthy Japanese Adult Participants

NCT04002752 | Completed Phase 1 FDA Drug

• 3 other identifiers: CR1086462019-000629-3173763989HPB1001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• 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)

Study Arms (3)

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

JNJ-73763989 DRUG

Participants will receive JNJ-73763989 as single subcutaneous injection.

Panel A: JNJ-73763989 or Placebo; Panel B: JNJ-73763989 or Placebo; Panel C: JNJ-73763989 or Placebo

Placebo DRUG

Participants will receive placebo matching to JNJ-73763989 as single subcutaneous injection.

Panel A: JNJ-73763989 or Placebo; Panel B: JNJ-73763989 or Placebo; Panel C: JNJ-73763989 or Placebo

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Janssen Sciences Ireland UC: lead

Study Sites (1)

PAREXEL International

London, HA1 3UJ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35695169 DERIVED

Study Officials

• Janssen Sciences Ireland UC Clinical Trial

  Janssen Sciences Ireland UC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: July 1, 2019
• Study Start: July 4, 2019
• Primary Completion: August 23, 2019
• Study Completion: August 23, 2019
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)