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A Single and Multiple Ascending Dose Study of Subcutaneously Administered JNJ-75220795

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ClinicalTrials.gov Identifier: NCT04844450
Recruitment Status : Completed
First Posted : April 14, 2021
Last Update Posted : August 18, 2023
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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Brief Summary:
The purpose of the study is to assess the safety and tolerability of single and multiple subcutaneous (SC) doses of JNJ-75220795.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Randomized, Multipart, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered JNJ-75220795
Actual Study Start Date : April 29, 2021
Actual Primary Completion Date : March 31, 2023
Actual Study Completion Date : March 31, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Single Ascending Dose (SAD)
Participants in cohorts 1-5 and cohorts 3a-5a will receive subcutaneous (SC) injection of single dose (Part A) of JNJ-75220795 or matching placebo.
 Drug: JNJ-75220795
JNJ-75220795 will be administered subcutaneously.

Drug: Placebo
Matching placebo will be administered subcutaneously.
Experimental: Multiple Ascending Dose (MAD)
Participants in cohorts 6-8 will receive SC injection of 2 doses (Part B) of JNJ-75220795 or matching placebo. Participants in cohorts 9-11 will receive SC injection of 4 doses (Part C) of JNJ-75220795 or matching placebo.
 Drug: JNJ-75220795
JNJ-75220795 will be administered subcutaneously.

Drug: Placebo
Matching placebo will be administered subcutaneously.


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 182 ]
    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 temperature, heart rate, respiratory rate, and blood pressure (supine) 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, 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 From Baseline in Liver Fat Content [ Time Frame: Baseline, weeks 6, 12, 18 and 24 ]
    Percent change from baseline in liver fat content will be reported.

  2. Plasma Concentration of JNJ-75220795 Over Time [ Time Frame: SAD: Predose, up to Day 3 and MAD: Predose, up to Day 86 ]
    Plasma samples will be analyzed to determine concentrations of JNJ-75220795.

  3. Percentage of Participants With Treatment-emergent Anti Drug Antibodies (ADA) [ Time Frame: Up to Day 168 ]
    Percentage of participants with treatment-emergent ADA will be assessed using a validated assay for ADA analysis.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with certain genetic predisposition 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
  • Weight stable defined as no more than 5% body weight loss or gain within 3 months prior to screening and no more than 5% body weight loss or gain from screening to randomization

Exclusion Criteria:

  • Known allergies, hypersensitivity, or intolerance to JNJ-75220795 or its 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
  • History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV 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): NCT04844450


Locations
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United States, Florida
Research Centers of America, LLC
Hollywood, Florida, United States, 33024
United States, Texas
Endeavor Clinical Trials, LLC
San Antonio, Texas, United States, 78240
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04844450    
Other Study ID Numbers: CR108997
75220795NAS1001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: April 14, 2021    Key Record Dates
Last Update Posted: August 18, 2023
Last Verified: August 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
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Digestive System Diseases