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

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

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

Study Overview

• Status: Completed
• Conditions: Fatty Liver Disease
• Intervention / Treatment: Drug: JNJ-75220795; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study@its.jnj.com

Study Locations

• United States
  • Florida
    • Hollywood, Florida, United States, 33024
      • Research Centers of America, LLC
  • Texas
    • San Antonio, Texas, United States, 78240
      • Endeavor Clinical Trials, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to Day 182
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.	Baseline, up to Day 168
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.	Baseline, up to Day 168
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.	Baseline, up to Day 168
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Abnormalities	Number of participants with change from baseline in ECG abnormalities will be reported.	Baseline, up to Day 168

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change From Baseline in Liver Fat Content	Percent change from baseline in liver fat content will be reported.	Baseline, weeks 6, 12, 18 and 24
Plasma Concentration of JNJ-75220795 Over Time	Plasma samples will be analyzed to determine concentrations of JNJ-75220795.	SAD: Predose, up to Day 3 and MAD: Predose, up to Day 86
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.	Up to Day 168

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2021
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 14, 2021

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 16, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver
• Other Study ID Numbers: CR108997; 75220795NAS1001 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No