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

Phase 1

Completed

• Conditions: Fatty Liver Disease
• Interventions: Drug: JNJ-75220795; Drug: Placebo

• Registration Number: NCT04844450
• Lead Sponsor: Janssen Research & Development, LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-04-13
• Study First Posted: 2021-04-14
• Study Start: 2021-04-29
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-16
• Last Update Posted: 2023-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Multiple Ascending Dose (MAD)	JNJ-75220795	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.
Multiple Ascending Dose (MAD)	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.
Single Ascending Dose (SAD)	JNJ-75220795	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.
Single Ascending Dose (SAD)	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Signs and Symptoms/ Adverse Events (AEs)	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.
Number of Participants With Change From Baseline in Clinical Laboratory Abnormalities	Baseline, up to Day 168	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 Vital Signs Abnormalities	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.
Number of Participants With Change From Baseline in Physical Examination Abnormalities	Baseline, up to Day 168	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	Baseline, up to Day 168	Number of participants with change from baseline in ECG abnormalities will be reported.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Liver Fat Content	Baseline, weeks 6, 12, 18 and 24	Percent change from baseline in liver fat content will be reported.
Plasma Concentration of JNJ-75220795 Over Time	SAD: Predose, up to Day 3 and MAD: Predose, up to Day 86	Plasma samples will be analyzed to determine concentrations of JNJ-75220795.
Percentage of Participants With Treatment-emergent Anti Drug Antibodies (ADA)	Up to Day 168	Percentage of participants with treatment-emergent ADA will be assessed using a validated assay for ADA analysis.

Trial Locations

Locations (2)

Research Centers of America, LLC; 🇺🇸 Hollywood, Florida, United States

Endeavor Clinical Trials, LLC; 🇺🇸 San Antonio, Texas, United States