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

Primary Purpose

Fatty Liver Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
JNJ-75220795
Placebo
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatty Liver Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Centers of America, LLC
  • Endeavor Clinical Trials, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Single Ascending Dose (SAD)

Multiple Ascending Dose (MAD)

Arm Description

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.

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.

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 temperature, heart rate, respiratory rate, and blood pressure (supine) 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, 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 From Baseline in Liver Fat Content
Percent change from baseline in liver fat content will be reported.
Plasma Concentration of JNJ-75220795 Over Time
Plasma samples will be analyzed to determine concentrations of JNJ-75220795.
Percentage of Participants With Treatment-emergent Anti Drug Antibodies (ADA)
Percentage of participants with treatment-emergent ADA will be assessed using a validated assay for ADA analysis.

Full Information

First Posted
April 13, 2021
Last Updated
August 16, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04844450
Brief Title
A Single and Multiple Ascending Dose Study of Subcutaneously Administered JNJ-75220795
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 29, 2021 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatty Liver Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Ascending Dose (SAD)
Arm Type
Experimental
Arm Description
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.
Arm Title
Multiple Ascending Dose (MAD)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
JNJ-75220795
Intervention Description
JNJ-75220795 will be administered subcutaneously.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo will be administered subcutaneously.
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 182
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 temperature, heart rate, respiratory rate, and blood pressure (supine) 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, 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 From Baseline in Liver Fat Content
Description
Percent change from baseline in liver fat content will be reported.
Time Frame
Baseline, weeks 6, 12, 18 and 24
Title
Plasma Concentration of JNJ-75220795 Over Time
Description
Plasma samples will be analyzed to determine concentrations of JNJ-75220795.
Time Frame
SAD: Predose, up to Day 3 and MAD: Predose, up to Day 86
Title
Percentage of Participants With Treatment-emergent Anti Drug Antibodies (ADA)
Description
Percentage of participants with treatment-emergent ADA will be assessed using a validated assay for ADA analysis.
Time Frame
Up to Day 168

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Research Centers of America, LLC
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Endeavor Clinical Trials, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States

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

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