Clinical trial NCT05039710: A Study of JNJ-75220795 in Japanese Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Fatty Liver
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2021-09-09
Enrollment: 9
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Treatment-emergent Signs and Symptoms/Adverse Events (AEs)
timeFrame: Up to Day 168
measure: Number of Participants With Change From Baseline in Vital Signs Abnormalities
timeFrame: Baseline, Up to Day 168
measure: Number of Participants With Change From Baseline in Clinical Laboratory Abnormalities
timeFrame: Baseline, Up to Day 168
measure: Number of Participants With Change From Baseline in Physical Examination Abnormalities
timeFrame: Baseline, Up to Day 168
measure: Number of Participants With Change From Baseline in Electrocardiogram (ECG) Abnormalities
timeFrame: Baseline, Up to Day 168
Secondary outcomes:
measure: Percent Change in Liver Fat Content Measured by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
timeFrame: From Baseline to Weeks 6, 12, 18, and 24
measure: Maximum Observed Plasma Concentration (Cmax) of JNJ-75220795
timeFrame: Predose up to 48 hours postdose (up to Day 3)
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-75220795
timeFrame: Predose up to 48 hours postdose (up to Day 3)
measure: Apparent Elimination Half-Life (t1/2) of JNJ-75220795
timeFrame: Predose up to 48 hours postdose (up to Day 3)
measure: Area Under the Plasma Concentration Time Curve of JNJ-75220795 from Time Zero to Infinite time (AUC [0-Infinity])
timeFrame: Predose up to 48 hours postdose (up to Day 3)
measure: Area Under the Plasma Concentration versus Time Curve of JNJ-75220795 from Time Zero to Time of the Last Measurable Concentration (AUC [0-Last])
timeFrame: Predose up to 48 hours postdose (up to Day 3)
measure: Total Apparent Clearance (CL/F) of JNJ-75220795
timeFrame: Predose up to 48 hours postdose (up to Day 3)
measure: Apparent Volume of Distribution (Vd/F) of JNJ-75220795
timeFrame: Predose up to 48 hours postdose (up to Day 3)
measure: Number of Participants with Treatment Emergent Anti-drug Antibody (ADA)
timeFrame: Up to Day 168
Other outcomes:
Locations:
city: Fukuoka-shi
country: Japan
facility: Souseikai Fukuoka Mirai Hospital
city: Shinjuku-ku
country: Japan
facility: Medical Corporation Heishinkai ToCROM Clinic
city: Suita-city
country: Japan
facility: Heishinkai TOCROM Clinic
city: Tokyo
country: Japan
facility: Sumida Hospital
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: