A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of JNJ-77474462 (Bermekimab) in Healthy Participants of Japanese Descent Following Administration of Single Ascending Subcutaneous Doses
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of Participants with Clinically Significant Changes in Electrocardiograms (ECGs) Waveform
研究概览
简要总结
The purpose of the study is to assess the safety and tolerability of JNJ-77474462 following single subcutaneous (SC) administration to healthy participants of Japanese descent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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
- •Participant must be of first to third generation Japanese descent
- •Participant must be otherwise healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and Day-
- •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
- •Participant must be otherwise healthy on the basis of clinical laboratory tests performed at screening and Day-
- •If the results of the serum chemistry panel including hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
- •Participant must have a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2) (BMI = weight/height^2) and a body weight of between 50 to 90 kg inclusive
- •A female participant must have a negative pregnancy test at screening and on Day -1
排除标准
- •Coexisting Medical Conditions or Past Medical History: 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
- •Coexisting Medical Conditions or Past Medical History: Has known allergies, hypersensitivity, or intolerance to JNJ-77474462 or its excipients, or any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies or antibody fragments, or to any components of the formulation of JNJ-77474462 and its excipients used in this study
- •Malignancy or Increased Potential for Malignancy: Has a history of malignancy before screening. Exceptions are squamous and basal cell carcinomas of the skin, carcinoma in situ of the cervix, or a malignancy which is considered cured with minimal risk and no evidence of recurrence within 5 years prior to screening
- •Concomitant or Previous Medical Therapies Received: Participant is currently enrolled in an investigational study or has received an investigational intervention (including investigational vaccines or devices) 5 half-lives or 8 weeks prior to screening (whichever is longer)
- •Concomitant or Previous Medical Therapies Received: Has received over the counter medications (including vitamins/multivitamins supplements, corticosteroids, acetaminophen/paracetamol, aspirin, decongestants, antihistamines and other non-steroidal anti-inflammatory drugs), and herbal medication (including, but not limited to, herbal tea, St. John's Wort, and cannabidol) within 2 weeks prior to first study intervention administration unless approved by the investigator and sponsor medical monitor
- •Infections or Predisposition to Infections: has an active acute or clinically significant chronic infection
研究组 & 干预措施
Cohort 1: JNJ-77474462 (Low Dose) or Placebo
Participants will receive single low dose of JNJ-77474462 or matching placebo as subcutaneous (SC) injection.
干预措施: JNJ-77474462 (Drug)
Cohort 1: JNJ-77474462 (Low Dose) or Placebo
Participants will receive single low dose of JNJ-77474462 or matching placebo as subcutaneous (SC) injection.
干预措施: Placebo (Drug)
Cohort 2: JNJ-77474462 (Medium Dose) or Placebo
Participants will receive single medium dose of JNJ-77474462 or matching placebo as SC injection.
干预措施: JNJ-77474462 (Drug)
Cohort 2: JNJ-77474462 (Medium Dose) or Placebo
Participants will receive single medium dose of JNJ-77474462 or matching placebo as SC injection.
干预措施: Placebo (Drug)
Cohort 3: JNJ-77474462 (High Dose) or Placebo
Participants will receive single high dose of JNJ-77474462 or matching placebo as SC injection.
干预措施: JNJ-77474462 (Drug)
Cohort 3: JNJ-77474462 (High Dose) or Placebo
Participants will receive single high dose of JNJ-77474462 or matching placebo as SC injection.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Clinically Significant Changes in Electrocardiograms (ECGs) Waveform
时间窗: Up to Week 12
Number of participants with clinically significant changes in ECGs waveform (example: changes in T-wave morphology or the occurrence of U-waves) will be reported.
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
时间窗: Up to Week 16
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. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Number of Participants with Serious Adverse Events (SAEs)
时间窗: Up to Week 16
A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Number of Participants with Clinically Significant Changes in Chemistry
时间窗: Up to Week 12
Number of participants with clinically significant changes in chemistry (such as Sodium, Potassium, Chloride, Bicarbonate,glucose, Total bilirubin, Uric acid) will be reported.
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by System Organ Class (SOC) Reported in two or More Participants
时间窗: Up to Week 16
An 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. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment.
Number of Participants with Clinically Significant Changes in Vital Signs
时间窗: Up to Week 12
Number of participants with clinically significant changes in vital signs (temperature, pulse/heart rate, respiratory rate, blood pressure) will be reported.
Number of Participants with Clinically Significant Changes in Hematology
时间窗: Up to Week 12
Number of participants with clinically significant changes in hematology (such as platelet count, Red blood cell count \[RBS\], Hemoglobin, Hematocrit, RBC Indices, WBCs) will be reported.
Number of Participants with Clinically Significant Changes in Urinalysis
时间窗: Up to Week 12
Number of participants with clinically significant changes in urinalysis (such as Specific gravity, pH, Glucose,Protein, WBCs, Bacteria) will be reported.
次要结局
- Area Under the Plasma/Serum Concentration-time Curve from Time Zero to Infinite Time (AUC[0-infinity])(Up to Week 12)
- Apparent Volume of Distribution (Vz/F)(Up to Week 12)
- Number of Participants with Antibodies to JNJ-77474462(Up to Week 12)
- Area Under the Plasma/Serum Concentration-time Curve from Time Zero To Time Of the Last Quantifiable Concentrations (AUC[0-last])(Up to Week 12)
- Time to Reach Maximum Observed Concentration (Tmax)(Up to Week 12)
- Maximum Observed Concentration (Cmax)(Up to Week 12)
- Terminal Half-life (T1/2)(Up to Week 12)
- Apparent Total Systemic Clearance (CL/F)(Up to Week 12)