A Study of JNJ-77474462 (Bermekimab) in Healthy Chinese Participants
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: JNJ-77474462 Participants will receive a single subcutaneous (SC) Dose 1 of JNJ-77474462 on Day 1 in Cohort 1, a single SC Dose 2 of JNJ-77474462 on Day 1 in Cohort 2 and a single SC Dose 3 of JNJ-77474462 on Day 1 in Cohort 3. |
Drug: JNJ-77474462
JNJ-77474462 will be administered subcutaneously.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Maximum Observed Serum Concentration (Cmax) of JNJ-77474462 [Up to Day 85]
Cmax is defined as the maximum observed serum concentration of JNJ-77474462.
- Time to Reach Maximum Observed Serum Concentration (Tmax) of JNJ-77474462 [Up to Day 85]
Tmax is defined as the time to reach maximum observed serum concentration of JNJ-77474462.
- Area Under the Serum Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-Infinity]) of JNJ-77474462 [Up to Day 85]
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.
- 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 [Up to Day 85]
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.
- Terminal Half-life (T1/2) of JNJ-77474462 [Up to Day 85]
T1/2 will be reported. T1/2 is defined as the terminal half-life of JNJ-77474462.
- Apparent Total Systemic Clearance after Extravascular Administration (CL/F) of JNJ-77474462 [Up to Day 85]
CL/F is defined as the apparent total systemic clearance after extravascular administration of JNJ-77474462.
- Apparent Volume of Distribution Based on Terminal Phase After Extravascular Administration (Vz/F) of JNJ-77474462 [Up to Day 85]
Vz/F is defined as the apparent volume of distribution based on terminal phase after extravascular administration of JNJ-77474462.
Secondary Outcome Measures
- Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity [Up to Day 85]
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.
- Percentage of Participants with Serious Adverse Events (SAEs) [Up to Day 85]
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.
- Number of Participants with Clinically Significant Changes in Vital Signs [Up to Day 85]
Number of participants with clinically significant changes in vital signs (temperature, pulse/heart rate, respiratory rate and blood pressure) will be reported.
- Number of Participants with Clinically Significant Changes in Electrocardiograms (ECGs) [Up to Day 85]
Number of participants with clinically significant changes in ECGs will be reported.
- Number of Participants with Clinically Significant Changes in Hematology Parameters [Up to Day 85]
Number of participants with clinically significant changes in hematology parameters will be reported.
- Number of Participants with Clinically Significant Changes in Chemistry Parameters [Up to Day 85]
Number of participants with clinically significant changes in chemistry parameters will be reported.
- Number of Participants with Clinically Significant Changes in Urinalysis [Up to Day 85]
Number of participants with clinically significant changes in urinalysis will be reported.
- Number of Participants with Presence of Antibodies to JNJ-77474462 [Up to Day 85]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Have a body mass index (BMI) between 18 and 27.9 kilograms per meter square (kg/m2) (BMI = weight/height2), inclusive, and a body weight of between 50 to 90 kg, inclusive
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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
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A female of childbearing potential must have a negative pregnancy test at screening and on Day -2 to -1
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Must have 3 quadrants on the abdomen where the skin is not tender, bruised, red, scaly, hardened, or tattooed for subcutaneous (SC) administration
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Must be a nonsmoker or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study
Exclusion Criteria:
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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
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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
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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)
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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
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Has tested positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV) and treponema pallidum-specific antibody
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nanfang Hospital of Southern Medical Hospital | Guangzhou | China | 510515 |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR109109
- 77474462HDS1001