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
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- Maximum Observed Serum Concentration (Cmax) of JNJ-77474462
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 -
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: JNJ-77474462 (Drug)
结局指标
主要结局
Maximum Observed Serum Concentration (Cmax) of JNJ-77474462
时间窗: 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
时间窗: 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 the Time Corresponding to the Last Quantifiable Concentration (AUC [0-Last]) of JNJ-77474462
时间窗: 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.
Area Under the Serum Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-Infinity]) of JNJ-77474462
时间窗: 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.
Apparent Total Systemic Clearance after Extravascular Administration (CL/F) of JNJ-77474462
时间窗: Up to Day 85
CL/F is defined as the apparent total systemic clearance after extravascular administration of JNJ-77474462.
Terminal Half-life (T1/2) of JNJ-77474462
时间窗: Up to Day 85
T1/2 will be reported. T1/2 is defined as the terminal half-life of JNJ-77474462.
Apparent Volume of Distribution Based on Terminal Phase After Extravascular Administration (Vz/F) of JNJ-77474462
时间窗: Up to Day 85
Vz/F is defined as the apparent volume of distribution based on terminal phase after extravascular administration of JNJ-77474462.
次要结局
- Number of Participants with Clinically Significant Changes in Vital Signs(Up to Day 85)
- Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) by Severity(Up to Day 85)
- Percentage of Participants with Serious Adverse Events (SAEs)(Up to Day 85)
- Number of Participants with Clinically Significant Changes in Electrocardiograms (ECGs)(Up to Day 85)
- Number of Participants with Clinically Significant Changes in Hematology Parameters(Up to Day 85)
- Number of Participants with Clinically Significant Changes in Chemistry Parameters(Up to Day 85)
- Number of Participants with Clinically Significant Changes in Urinalysis(Up to Day 85)
- Number of Participants with Presence of Antibodies to JNJ-77474462(Up to Day 85)