A Study of JNJ-75220795 in Japanese Participants

A Double-Blind, Placebo-Controlled, Randomized, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered JNJ-75220795 in Japanese Participants

The purpose of this study is to assess the safety and tolerability of single subcutaneous (SC) dose of JNJ-75220795 in Japanese participants.

Study Overview

• Status: Terminated
• Conditions: Fatty Liver
• Intervention / Treatment: Drug: JNJ-75220795; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka-shi, Japan, 813-0017
    • SOUSEIKAI Fukuoka Mirai Hospital
  • Shinjuku-ku, Japan, 160-0008
    • Medical Corporation Heishinkai ToCROM Clinic
  • Suita-city, Japan, 565-0853
    • Heishinkai TOCROM Clinic
  • Tokyo, Japan, 130-0004
    • Sumida Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants with certain genetic predispositions to non-alcoholic fatty liver disease (NAFLD) determined at screening
• Presence of liver steatosis at screening
• Participants on anti-hypertensive and/or lipid lowering medications and/or glucose lowering medications must be on stable dose(s) for at least 4 weeks prior to screening
• Body mass index between 18 kilograms per meter square (kg/m^2) and 40 kg/m^2 inclusive, and body weight stable defined as no more than 5 percent (%) body weight loss or gain within 3 months prior to screening (based on participant's report) and no more than 5% body weight loss or gain from screening to randomization

Exclusion Criteria:

• Known allergies, hypersensitivity, or intolerance to excipients
• History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HbsAg or anti-HCV at screening. And/or history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV or syphilis at screening
• Participants with clinical or biochemical (international normalized ratio [INR] greater than [>] 1.2, or platelet count less than [<] lower limits of normal [LLN]) evidence of hepatic decompensation at screening or baseline
• Estimated glomerular filtration rate (eGFR) by Japanese eGFR formula below 60 milliliters per minute [mL/min] at screening
• Thyroid stimulating hormone (TSH) levels, free triiodothyronine (FT3) and free thyroxine (FT4) outside normal limits of the clinical laboratory's reference range at screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: JNJ-75220795 or Placebo; Participants will receive single subcutaneous (SC) dose of JNJ-75220795 Dose 1 or matching placebo on Day 1 in Cohort 1.	Drug: JNJ-75220795; JNJ-75220795 will be administered as SC injection.; Other: Placebo; Matching placebo will be administered as SC injection.
Experimental: Cohort 2: JNJ-75220795 or Placebo; Participants will receive single SC dose of JNJ-75220795 Dose 2 or matching placebo on Day 1 in Cohort 2.	Drug: JNJ-75220795; JNJ-75220795 will be administered as SC injection.; Other: Placebo; Matching placebo will be administered as SC injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Treatment-emergent Signs and Symptoms/Adverse Events (AEs)	Number of participants with treatment-emergent signs and symptoms/adverse events (including allergic reactions/hypersensitivity and local injection site reactions) will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Treatment-emergent adverse events (TEAEs) are defined as AEs with onset or worsening on or after date of first dose of study treatment.	Up to Day 168
Number of Participants With Change From Baseline in Vital Signs Abnormalities	Number of participants with change from baseline in vital signs abnormalities including body temperature (axillary), pulse, respiratory rate and blood pressure will be reported.	Baseline, Up to Day 168
Number of Participants With Change From Baseline in Clinical Laboratory Abnormalities	Number of participants with change from baseline in clinical laboratory abnormalities including hematology, serum chemistry and urinalysis will be reported.	Baseline, Up to Day 168
Number of Participants With Change From Baseline in Physical Examination Abnormalities	Number of participants with change from baseline in physical examination abnormalities will be reported.	Baseline, Up to Day 168
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Abnormalities	Number of participants with change from baseline in ECG abnormalities will be reported.	Baseline, Up to Day 168

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in Liver Fat Content Measured by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)	Percent change in liver fat content as measured by MRI-PDFF will be reported.	From Baseline to Weeks 6, 12, 18, and 24
Maximum Observed Plasma Concentration (Cmax) of JNJ-75220795	Cmax of JNJ-75220795 will be reported.	Predose up to 48 hours postdose (up to Day 3)
Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-75220795	Tmax of JNJ-75220795 will be reported.	Predose up to 48 hours postdose (up to Day 3)
Apparent Elimination Half-Life (t1/2) of JNJ-75220795	t1/2 is defined as apparent elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve.	Predose up to 48 hours postdose (up to Day 3)
Area Under the Plasma Concentration Time Curve of JNJ-75220795 from Time Zero to Infinite time (AUC [0-Infinity])	AUC (0-Infinity) is defined as the area under the plasma concentration versus time curve of JNJ-75220795 from time zero to infinite time.	Predose up to 48 hours postdose (up to Day 3)
Area Under the Plasma Concentration versus Time Curve of JNJ-75220795 from Time Zero to Time of the Last Measurable Concentration (AUC [0-Last])	AUC (0-Last) is defined as area under the plasma concentration versus time curve of JNJ-75220795 from time zero to time of the last measurable concentration.	Predose up to 48 hours postdose (up to Day 3)
Total Apparent Clearance (CL/F) of JNJ-75220795	CL/F is defined as total apparent clearance of JNJ-75220795.	Predose up to 48 hours postdose (up to Day 3)
Apparent Volume of Distribution (Vd/F) of JNJ-75220795	Vd/F is defined as apparent volume of distribution of JNJ-75220795.	Predose up to 48 hours postdose (up to Day 3)
Number of Participants with Treatment Emergent Anti-drug Antibody (ADA)	Number of participants with treatment emergent ADA will be reported.	Up to Day 168

Collaborators and Investigators

• Sponsor: Janssen Pharmaceutical K.K.
• Investigators: Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial, Janssen Pharmaceutical K.K.

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2021
• Primary Completion (Actual): February 17, 2023
• Study Completion (Actual): February 17, 2023

Study Registration Dates

• First Submitted: September 1, 2021
• First Submitted That Met QC Criteria: September 1, 2021
• First Posted (Actual): September 9, 2021

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 14, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver
• Other Study ID Numbers: CR109081; 75220795NAS1002 (Other Identifier: Janssen Pharmaceutical K.K., Japan)

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