A Study of JNJ-77474462 (Bermekimab) in Healthy Chinese Participants

Healthy Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05252520
• Other study ID #: CR109109
• Secondary ID: 77474462HDS1001
• Status: Withdrawn
• Phase: Phase 1
• Start date: May 1, 2023
• Est. completion date: November 20, 2023

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 20, 2023
• Est. primary completion date: November 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• JNJ-77474462
JNJ-77474462 will be administered subcutaneously.

Locations

Country	Name	City	State
China	Nanfang Hospital of Southern Medical Hospital	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Serum Concentration (Cmax) of JNJ-77474462	Cmax is defined as the maximum observed serum concentration of JNJ-77474462.	Up to Day 85
Primary	Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-77474462	Tmax is defined as the time to reach maximum observed serum concentration of JNJ-77474462.	Up to Day 85
Primary	Area Under the Serum Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-Infinity]) of JNJ-77474462	AUC (0-infinity) is defined as the area under the serum concentration of JNJ-77474462 versus time curve from time zero to infinity with extrapolation of the terminal phase.	Up to Day 85
Primary	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	AUC (0-Last) is defined as the area under the serum concentration of JNJ-77474462 versus time curve from time zero to the time corresponding to the last quantifiable concentration.	Up to Day 85
Primary	Terminal Half-life (T1/2) of JNJ-77474462	T1/2 will be reported. T1/2 is defined as the terminal half-life of JNJ-77474462.	Up to Day 85
Primary	Apparent Total Systemic Clearance after Extravascular Administration (CL/F) of JNJ-77474462	CL/F is defined as the apparent total systemic clearance after extravascular administration of JNJ-77474462.	Up to Day 85
Primary	Apparent Volume of Distribution Based on Terminal Phase After Extravascular Administration (Vz/F) of JNJ-77474462	Vz/F is defined as the apparent volume of distribution based on terminal phase after extravascular administration of JNJ-77474462.	Up to Day 85
Secondary	Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity	Percentage of participants with TEAEs by severity will be reported. An adverse event (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. Any AE occurring at or after the initial administration of study intervention through Day 85 is considered to be treatment-emergent. Severity will be assessed based on the following categories: a) Mild: Awareness of symptoms that are easily tolerated, causing minimal discomfort and not interfering with everyday activities, b) Moderate: Sufficient discomfort is present to cause interference with normal activity and c) Severe: Extreme distress, causing significant impairment of functioning or incapacitation. Prevents normal everyday activities.	Up to Day 85
Secondary	Percentage of Participants with Serious Adverse Events (SAEs)	Percentage of participants with SAEs will be reported. A SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important to prevent one of the outcomes listed above.	Up to Day 85
Secondary	Number of Participants with Clinically Significant Changes in Vital Signs	Number of participants with clinically significant changes in vital signs (temperature, pulse/heart rate, respiratory rate and blood pressure) will be reported.	Up to Day 85
Secondary	Number of Participants with Clinically Significant Changes in Electrocardiograms (ECGs)	Number of participants with clinically significant changes in ECGs will be reported.	Up to Day 85
Secondary	Number of Participants with Clinically Significant Changes in Hematology Parameters	Number of participants with clinically significant changes in hematology parameters will be reported.	Up to Day 85
Secondary	Number of Participants with Clinically Significant Changes in Chemistry Parameters	Number of participants with clinically significant changes in chemistry parameters will be reported.	Up to Day 85
Secondary	Number of Participants with Clinically Significant Changes in Urinalysis	Number of participants with clinically significant changes in urinalysis will be reported.	Up to Day 85
Secondary	Number of Participants with Presence of Antibodies to JNJ-77474462	Number of participants with presence of antibodies to JNJ-77474462 will be reported. The detection and characterization of antibodies to JNJ-77474462 will be performed using a validated drug-tolerant method.	Up to Day 85