Clinical trial NCT04844450: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fatty Liver Disease
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-04-14
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Signs and Symptoms/ Adverse Events (AEs)
timeFrame: Up to Day 182
measure: Number of Participants With Change From Baseline in Vital Signs Abnormalities
timeFrame: Baseline, up to Day 168
measure: Number of Participants With Change From Baseline in Clinical Laboratory Abnormalities
timeFrame: Baseline, up to Day 168
measure: Number of Participants With Change From Baseline in Physical Examination Abnormalities
timeFrame: Baseline, up to Day 168
measure: Number of Participants With Change From Baseline in Electrocardiogram (ECG) Abnormalities
timeFrame: Baseline, up to Day 168
Secondary outcomes:
measure: Percent Change From Baseline in Liver Fat Content
timeFrame: Baseline, weeks 6, 12, 18 and 24
measure: Plasma Concentration of JNJ-75220795 Over Time
timeFrame: SAD: Predose, up to Day 3 and MAD: Predose, up to Day 86
measure: Percentage of Participants With Treatment-emergent Anti Drug Antibodies (ADA)
timeFrame: Up to Day 168
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: Research Centers of America, LLC
state: Florida
city: San Antonio
country: United States
facility: Endeavor Clinical Trials, LLC
state: Texas
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: