A Study of JNJ-73763989 in Healthy Chinese Adult Participants

NCT04586439 | Completed Phase 1 FDA Drug

• 2 other identifiers: CR10886773763989HPB1004
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the single-dose Pharmacokinetics of JNJ-73763976 and JNJ-73763924 following a subcutaneous (SC) injection of JNJ-73763989 (JNJ-3989) in healthy Chinese adult participants at 2 different doses, Dose 1 (Panel A) or Dose 2 (Panel B).

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

  Up to 4 Weeks

• Plasma Concentration of JNJ-73763989

  Plasma samples will be analyzed to determine concentrations of JNJ-73763989 (as the 2 triggers JNJ-73763976 and JNJ-73763924).

  Predose up to 48 hours postdose (up to Day 3)

• Urine Concentration of JNJ-73763989

  Urine samples will be analyzed to determine concentrations of JNJ-73763989 (as the 2 triggers JNJ-73763976 and JNJ-73763924).

  Predose up to 48 hours postdose (up to Day 3)

Study Arms (2)

Panel A: JNJ-73763989

EXPERIMENTAL

Participants will receive single subcutaneous (SC) injection of low dose of JNJ-73763989 on Day 1.

Drug: JNJ-73763989

Panel B: J NJ-73763989

EXPERIMENTAL

Participants will receive single SC injection of high dose of JNJ-73763989 on Day 1.

Drug: JNJ-73763989

Interventions

JNJ-73763989 DRUG

JNJ-73763989 will be administered (high or low dose) as single SC injection.

Panel A: JNJ-73763989; Panel B: J NJ-73763989

Eligibility Criteria

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

You may qualify if:

• Participant must be healthy based on physical examination, laboratory assessment, vital signs and electrocardiogram (ECG) at screening
• A female participant of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[hCG\]) pregnancy test 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 and a female participant must agree not to donate eggs (ova, oocytes) during the study until at least 90 days after receiving the study drug
• Participant must not use nicotine-containing substances including tobacco products for at least 3 months prior to screening until completion of the study
• Participant must have suitable veins for cannulation and/or repeated venipuncture

You may not qualify if:

• Participant with a history of cardiac arrhythmias (example, premature ventricular contractions), history of risk factors for Torsade de Pointes syndrome (example, hypokalemia, family history of long QT Syndrome)
• Participant with human immunodeficiency virus 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 HBsAg), or hepatitis C virus (HCV) infection (confirmed by HCV antibody), or hepatitis E infection (confirmed by hepatitis E antibody IgM) at screening
• Participant has positive test result(s) for alcohol and/or drugs of abuse (including amphetamines, benzodiazepines, cocaine, cannabinoids, opioids, and methadone) at screening and Day-1
• Participant has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant or that could prevent, limit, or confound the protocol-specified assessments. This may include but is not limited to renal dysfunction estimated Glomerular Filtration Rate (GFR) \<60 millimeter per minute (mL/min) /1.73 m\^2 at screening

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Peking University Third Hospital

Beijing, 100089, China

Location

Related Publications (1)

• Li H, Niu X, Zhang Y, Zhang D, Zhang Y, Wang L, Miao Y, Jiang Y, Ji J, Chen Q, Wu X, Ediage EN, Kakuda TN, Biermer M. Pharmacokinetics, Safety, and Tolerability of the siRNA JNJ-73763989 in Healthy Chinese Adult Participants. Clin Pharmacol Drug Dev. 2023 Feb;12(2):175-180. doi: 10.1002/cpdd.1197. Epub 2022 Nov 22.

  PMID: 36415122 DERIVED

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 14, 2020
• Study Start: November 24, 2020
• Primary Completion: February 18, 2021
• Study Completion: February 18, 2021
• Last Updated: March 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)