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A Study of JNJ-75220795 in Japanese Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05039710
Recruitment Status : Terminated (Business Judgement)
First Posted : September 9, 2021
Last Update Posted : May 16, 2023
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fatty Liver Drug: JNJ-75220795 Other: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : November 8, 2021
Actual Primary Completion Date : February 17, 2023
Actual Study Completion Date : February 22, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: JNJ-75220795
JNJ-75220795 will be administered as SC injection.

Other: Placebo
Matching placebo will be administered as SC injection.
Experimental: 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.
 Drug: JNJ-75220795
JNJ-75220795 will be administered as SC injection.

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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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 Outcome Measures :
  1. Percent Change in Liver Fat Content Measured by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) [ Time Frame: From Baseline to Weeks 6, 12, 18, and 24 ]
    Percent change in liver fat content as measured by MRI-PDFF will be reported.

  2. Maximum Observed Plasma Concentration (Cmax) of JNJ-75220795 [ Time Frame: Predose up to 48 hours postdose (up to Day 3) ]
    Cmax of JNJ-75220795 will be reported.

  3. Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-75220795 [ Time Frame: Predose up to 48 hours postdose (up to Day 3) ]
    Tmax of JNJ-75220795 will be reported.

  4. Apparent Elimination Half-Life (t1/2) of JNJ-75220795 [ Time Frame: Predose up to 48 hours postdose (up to Day 3) ]
    t1/2 is defined as apparent elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve.

  5. Area Under the Plasma Concentration Time Curve of JNJ-75220795 from Time Zero to Infinite time (AUC [0-Infinity]) [ Time Frame: Predose up to 48 hours postdose (up to Day 3) ]
    AUC (0-Infinity) is defined as the area under the plasma concentration versus time curve of JNJ-75220795 from time zero to infinite time.

  6. Area Under the Plasma Concentration versus Time Curve of JNJ-75220795 from Time Zero to Time of the Last Measurable Concentration (AUC [0-Last]) [ Time Frame: Predose up to 48 hours postdose (up to Day 3) ]
    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.

  7. Total Apparent Clearance (CL/F) of JNJ-75220795 [ Time Frame: Predose up to 48 hours postdose (up to Day 3) ]
    CL/F is defined as total apparent clearance of JNJ-75220795.

  8. Apparent Volume of Distribution (Vd/F) of JNJ-75220795 [ Time Frame: Predose up to 48 hours postdose (up to Day 3) ]
    Vd/F is defined as apparent volume of distribution of JNJ-75220795.

  9. Number of Participants with Treatment Emergent Anti-drug Antibody (ADA) [ Time Frame: Up to Day 168 ]
    Number of participants with treatment emergent ADA will be reported.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05039710


Locations
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Japan
Souseikai Fukuoka Mirai Hospital
Fukuoka-shi, Japan, 813-0017
Corporation Heishinkai ToCROM Clinic
Shinjuku-ku, Japan, 160-0008
Corporation Heishinkai OCROM Clinic
Suita-city, Japan, 565-0853
Sumida Hospital
Tokyo, Japan, 130-0004
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
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Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.
More Information
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Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT05039710    
Other Study ID Numbers: CR109081
75220795NAS1002 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
First Posted: September 9, 2021    Key Record Dates
Last Update Posted: May 16, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
URL: https://www.janssen.com/clinical-trials/transparency

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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
Additional relevant MeSH terms:
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Fatty Liver
Liver Diseases
Digestive System Diseases