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
Overview
- Phase
- Phase 1
- Intervention
- JNJ-75220795
- Conditions
- Fatty Liver
- Sponsor
- Janssen Pharmaceutical K.K.
- Enrollment
- 9
- Locations
- 4
- Primary Endpoint
- Number of Participants with Treatment-emergent Signs and Symptoms/Adverse Events (AEs)
- Status
- Terminated
- Last Updated
- 8 months ago
Overview
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.
Investigators
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
Arms & Interventions
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.
Intervention: JNJ-75220795
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.
Intervention: Placebo
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.
Intervention: JNJ-75220795
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.
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Participants with Treatment-emergent Signs and Symptoms/Adverse Events (AEs)
Time Frame: Up to Day 168
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.
Number of Participants With Change From Baseline in Vital Signs Abnormalities
Time Frame: Baseline, Up to Day 168
Number of participants with change from baseline in vital signs abnormalities including body temperature (axillary), pulse, respiratory rate and blood pressure will be reported.
Number of Participants With Change From Baseline in Clinical Laboratory Abnormalities
Time Frame: Baseline, Up to Day 168
Number of participants with change from baseline in clinical laboratory abnormalities including hematology, serum chemistry and urinalysis will be reported.
Number of Participants With Change From Baseline in Physical Examination Abnormalities
Time Frame: Baseline, Up to Day 168
Number of participants with change from baseline in physical examination abnormalities will be reported.
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Abnormalities
Time Frame: Baseline, Up to Day 168
Number of participants with change from baseline in ECG abnormalities will be reported.
Secondary Outcomes
- Area Under the Plasma Concentration versus Time Curve of JNJ-75220795 from Time Zero to Time of the Last Measurable Concentration (AUC [0-Last])(Predose up to 48 hours postdose (up to Day 3))
- Total Apparent Clearance (CL/F) of JNJ-75220795(Predose up to 48 hours postdose (up to Day 3))
- Apparent Volume of Distribution (Vd/F) of JNJ-75220795(Predose up to 48 hours postdose (up to Day 3))
- Percent Change in Liver Fat Content Measured by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)(From Baseline to Weeks 6, 12, 18, and 24)
- Maximum Observed Plasma Concentration (Cmax) of JNJ-75220795(Predose up to 48 hours postdose (up to Day 3))
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-75220795(Predose up to 48 hours postdose (up to Day 3))
- Apparent Elimination Half-Life (t1/2) of JNJ-75220795(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])(Predose up to 48 hours postdose (up to Day 3))
- Number of Participants with Treatment Emergent Anti-drug Antibody (ADA)(Up to Day 168)