A Study of JNJ-75220795 in Japanese Participants

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

Official Title
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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

Conditions
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Fatty Liver

Intervention / Treatment
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* Drug: JNJ-75220795
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |