A Study of JNJ-75220795 in Japanese Participants

Fatty Liver Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05039710
• Other study ID #: CR109081
• Secondary ID: 75220795NAS1002
• Status: Terminated
• Phase: Phase 1
• Start date: November 8, 2021
• Est. completion date: February 22, 2023

Study information

• Verified date: May 2023
• Source: Janssen Pharmaceutical K.K.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: February 22, 2023
• Est. primary completion date: February 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver

Intervention

Drug:
• JNJ-75220795
JNJ-75220795 will be administered as SC injection.

Other:
• Placebo
Matching placebo will be administered as SC injection.

Locations

Country	Name	City	State
Japan	Souseikai Fukuoka Mirai Hospital	Fukuoka-shi
Japan	Corporation Heishinkai ToCROM Clinic	Shinjuku-ku
Japan	Corporation Heishinkai OCROM Clinic	Suita-city
Japan	Sumida Hospital	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutical K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Number of Participants with Treatment Emergent Anti-drug Antibody (ADA)	Number of participants with treatment emergent ADA will be reported.	Up to Day 168