Clinical trial NCT05252520: A Study of JNJ-77474462 (Bermekimab) in Healthy Chinese Participants
Official title: A Phase 1 Open-label Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of JNJ-77474462 (Bermekimab) in Healthy Chinese Participants Following Subcutaneous Administration
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-02-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-77474462 following single ascending dose subcutaneous (SC) administration to healthy Chinese participants.


Eligibility criteria: Inclusion Criteria:

* Have a body mass index (BMI) between 18 and 27.9 kilograms per meter square (kg/m\^2) (BMI = weight/height\^2), inclusive, and a body weight of between 50 to 90 kg, inclusive
* Otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and Day -2 to -1. Any abnormalities must be considered not clinically significant and this determination must be recorded in the participant's source documents and initialed by the investigator
* A female of childbearing potential must have a negative pregnancy test at screening and on Day -2 to -1
* Must have 3 quadrants on the abdomen where the skin is not tender, bruised, red, scaly, hardened, or tattooed for subcutaneous (SC) administration
* Must be a nonsmoker or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study

Exclusion Criteria:

* History of any clinically significant medical illness or medical disorders the investigator considers should exclude the participant, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, ophthalmological disorders, endocrine, neoplastic disease, renal or urinary tract diseases, or dermatological disease
* History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 12 months before Screening or positive test result(s) for alcohol or drugs of abuse (including morphine, ketamine, tetrahydrocannabinolic acid, methamphetamine, dimethylene dioxoamphetamine, cocaine) at Screening and Day -2 to -1
* Have a history of active granulomatous infection (including histoplasmosis or coccidioidomycosis), nontuberculous mycobacterial infection or opportunistic infection (including pneumocystosis, aspergillosis, and disseminated herpes zoster defined as zoster with central nervous system involvement or zoster spreading to more than 2 adjacent dermatomes)
* Has a chest radiograph within 3 months before the first administration of study intervention that shows an abnormality suggestive of a malignancy or current active infection, including tuberculosis (TB). A chest computerized tomography (CT) scan is also acceptable if already available or obtained outside of the study protocol
* Has tested positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV) and treponema pallidum-specific antibody

Primary outcomes:
measure: Maximum Observed Serum Concentration (Cmax) of JNJ-77474462
timeFrame: Up to Day 85
measure: Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-77474462
timeFrame: Up to Day 85
measure: Area Under the Serum Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-Infinity]) of JNJ-77474462
timeFrame: Up to Day 85
measure: Area Under the Serum Concentration Versus Time Curve from Time Zero to the Time Corresponding to the Last Quantifiable Concentration (AUC [0-Last]) of JNJ-77474462
timeFrame: Up to Day 85
measure: Terminal Half-life (T1/2) of JNJ-77474462
timeFrame: Up to Day 85
measure: Apparent Total Systemic Clearance after Extravascular Administration (CL/F) of JNJ-77474462
timeFrame: Up to Day 85
measure: Apparent Volume of Distribution Based on Terminal Phase After Extravascular Administration (Vz/F) of JNJ-77474462
timeFrame: Up to Day 85
Secondary outcomes:
measure: Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity
timeFrame: Up to Day 85
measure: Percentage of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to Day 85
measure: Number of Participants with Clinically Significant Changes in Vital Signs
timeFrame: Up to Day 85
measure: Number of Participants with Clinically Significant Changes in Electrocardiograms (ECGs)
timeFrame: Up to Day 85
measure: Number of Participants with Clinically Significant Changes in Hematology Parameters
timeFrame: Up to Day 85
measure: Number of Participants with Clinically Significant Changes in Chemistry Parameters
timeFrame: Up to Day 85
measure: Number of Participants with Clinically Significant Changes in Urinalysis
timeFrame: Up to Day 85
measure: Number of Participants with Presence of Antibodies to JNJ-77474462
timeFrame: Up to Day 85
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: