Back to resultsA Study of JNJ-75220795 in Japanese Participants
Primary Purpose
Fatty Liver
Status
Terminated
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
JNJ-75220795
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Fatty Liver
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
Sites / Locations
- Souseikai Fukuoka Mirai Hospital
- Corporation Heishinkai ToCROM Clinic
- Corporation Heishinkai OCROM Clinic
- Sumida Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort 1: JNJ-75220795 or Placebo
Cohort 2: JNJ-75220795 or Placebo
Arm Description
Participants will receive single subcutaneous (SC) dose of JNJ-75220795 Dose 1 or matching placebo on Day 1 in Cohort 1.
Participants will receive single SC dose of JNJ-75220795 Dose 2 or matching placebo on Day 1 in Cohort 2.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Abnormalities
Number of participants with change from baseline in ECG abnormalities will be reported.
Secondary Outcome Measures
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.
Maximum Observed Plasma Concentration (Cmax) of JNJ-75220795
Cmax of JNJ-75220795 will be reported.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-75220795
Tmax of JNJ-75220795 will be reported.
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.
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.
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.
Total Apparent Clearance (CL/F) of JNJ-75220795
CL/F is defined as total apparent clearance of JNJ-75220795.
Apparent Volume of Distribution (Vd/F) of JNJ-75220795
Vd/F is defined as apparent volume of distribution of JNJ-75220795.
Number of Participants with Treatment Emergent Anti-drug Antibody (ADA)
Number of participants with treatment emergent ADA will be reported.
Full Information
NCT ID
NCT05039710
First Posted
September 1, 2021
Last Updated
May 12, 2023
Sponsor
Janssen Pharmaceutical K.K.
1. Study Identification
Unique Protocol Identification Number
NCT05039710
Brief Title
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Business Judgement
Study Start Date
November 8, 2021 (Actual)
Primary Completion Date
February 17, 2023 (Actual)
Study Completion Date
February 22, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Pharmaceutical K.K.
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatty Liver
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1: JNJ-75220795 or Placebo
Arm Type
Experimental
Arm Description
Participants will receive single subcutaneous (SC) dose of JNJ-75220795 Dose 1 or matching placebo on Day 1 in Cohort 1.
Arm Title
Cohort 2: JNJ-75220795 or Placebo
Arm Type
Experimental
Arm Description
Participants will receive single SC dose of JNJ-75220795 Dose 2 or matching placebo on Day 1 in Cohort 2.
Intervention Type
Drug
Intervention Name(s)
JNJ-75220795
Intervention Description
JNJ-75220795 will be administered as SC injection.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matching placebo will be administered as SC injection.
Primary Outcome Measure Information:
Title
Number of Participants with Treatment-emergent Signs and Symptoms/Adverse Events (AEs)
Description
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.
Time Frame
Up to Day 168
Title
Number of Participants With Change From Baseline in Vital Signs Abnormalities
Description
Number of participants with change from baseline in vital signs abnormalities including body temperature (axillary), pulse, respiratory rate and blood pressure will be reported.
Time Frame
Baseline, Up to Day 168
Title
Number of Participants With Change From Baseline in Clinical Laboratory Abnormalities
Description
Number of participants with change from baseline in clinical laboratory abnormalities including hematology, serum chemistry and urinalysis will be reported.
Time Frame
Baseline, Up to Day 168
Title
Number of Participants With Change From Baseline in Physical Examination Abnormalities
Description
Number of participants with change from baseline in physical examination abnormalities will be reported.
Time Frame
Baseline, Up to Day 168
Title
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Abnormalities
Description
Number of participants with change from baseline in ECG abnormalities will be reported.
Time Frame
Baseline, Up to Day 168
Secondary Outcome Measure Information:
Title
Percent Change in Liver Fat Content Measured by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
Description
Percent change in liver fat content as measured by MRI-PDFF will be reported.
Time Frame
From Baseline to Weeks 6, 12, 18, and 24
Title
Maximum Observed Plasma Concentration (Cmax) of JNJ-75220795
Description
Cmax of JNJ-75220795 will be reported.
Time Frame
Predose up to 48 hours postdose (up to Day 3)
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-75220795
Description
Tmax of JNJ-75220795 will be reported.
Time Frame
Predose up to 48 hours postdose (up to Day 3)
Title
Apparent Elimination Half-Life (t1/2) of JNJ-75220795
Description
t1/2 is defined as apparent elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve.
Time Frame
Predose up to 48 hours postdose (up to Day 3)
Title
Area Under the Plasma Concentration Time Curve of JNJ-75220795 from Time Zero to Infinite time (AUC [0-Infinity])
Description
AUC (0-Infinity) is defined as the area under the plasma concentration versus time curve of JNJ-75220795 from time zero to infinite time.
Time Frame
Predose up to 48 hours postdose (up to Day 3)
Title
Area Under the Plasma Concentration versus Time Curve of JNJ-75220795 from Time Zero to Time of the Last Measurable Concentration (AUC [0-Last])
Description
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.
Time Frame
Predose up to 48 hours postdose (up to Day 3)
Title
Total Apparent Clearance (CL/F) of JNJ-75220795
Description
CL/F is defined as total apparent clearance of JNJ-75220795.
Time Frame
Predose up to 48 hours postdose (up to Day 3)
Title
Apparent Volume of Distribution (Vd/F) of JNJ-75220795
Description
Vd/F is defined as apparent volume of distribution of JNJ-75220795.
Time Frame
Predose up to 48 hours postdose (up to Day 3)
Title
Number of Participants with Treatment Emergent Anti-drug Antibody (ADA)
Description
Number of participants with treatment emergent ADA will be reported.
Time Frame
Up to Day 168
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Pharmaceutical K.K., Japan Clinical Trial
Organizational Affiliation
Janssen Pharmaceutical K.K.
Official's Role
Study Director
Facility Information:
Facility Name
Souseikai Fukuoka Mirai Hospital
City
Fukuoka-shi
ZIP/Postal Code
813-0017
Country
Japan
Facility Name
Corporation Heishinkai ToCROM Clinic
City
Shinjuku-ku
ZIP/Postal Code
160-0008
Country
Japan
Facility Name
Corporation Heishinkai OCROM Clinic
City
Suita-city
ZIP/Postal Code
565-0853
Country
Japan
Facility Name
Sumida Hospital
City
Tokyo
ZIP/Postal Code
130-0004
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency
Learn more about this trial
A Study of JNJ-75220795 in Japanese Participants
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