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

Fatty Liver Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04844450
• Other study ID #: CR108997
• Secondary ID: 75220795NAS1001
• Status: Completed
• Phase: Phase 1
• Start date: April 29, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: August 2023
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Fatty Liver Disease
• Liver Diseases

Intervention

Drug:
• JNJ-75220795
JNJ-75220795 will be administered subcutaneously.
• Placebo
Matching placebo will be administered subcutaneously.

Locations

Country	Name	City	State
United States	Research Centers of America, LLC	Hollywood	Florida
United States	Endeavor Clinical Trials, LLC	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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