A Phase 1 Study to Investigate the Pharmacokinetics and Pharmacodynamics of JNJ-77474462 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma 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 after single subcutaneous (SC) or intravenous (IV) administrations and the effect of formulation concentrations on PK of JNJ-77474462 in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Otherwise healthy on the basis of physical examination, medical history, vital signs, and 12 lead electrocardiogram (ECG) performed at screening. 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
- •Otherwise healthy on the basis of clinical laboratory tests performed at screening and Day
- •If the results of the serum chemistry panel, 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
- •A woman of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta hCG) at screening and a negative urine pregnancy test on Day -1
- •A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 90 days post study intervention administration
- •A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study intervention
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, neoplastic disease, renal or urinary tract diseases, or dermatological disease
- •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 of recurrence
- •Has or has had a serious infection (example: sepsis, pneumonia, or pyelonephritis), or have been hospitalized or received intravenous (IV) antibiotics for a serious infection during the 4 months prior to the screening visit
- •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)
- •Has received prescription medications within 2 weeks prior to first study intervention administration
研究组 & 干预措施
Cohort F: JNJ-77474462 SC (Wave 2)
Participants will receive single dose of JNJ-77474462 SC.
干预措施: JNJ-77474462 (Drug)
Cohort I: JNJ-77474462 IV (Wave 2)
Participants will receive single dose of JNJ-77474462 IV.
干预措施: JNJ-77474462 (Drug)
Cohort A: JNJ-77474462 SC (Wave 1)
Participants will receive single dose of JNJ-77474462 subcutaneously (SC).
干预措施: JNJ-77474462 (Drug)
Cohort B: JNJ-77474462 SC (Wave 1)
Participants will receive single dose of JNJ-77474462 SC.
干预措施: JNJ-77474462 (Drug)
Cohort C: JNJ-77474462 SC (Wave 1)
Participants will receive single dose of JNJ-77474462 SC.
干预措施: JNJ-77474462 (Drug)
Cohort D: JNJ-77474462 SC (Wave 1)
Participants will receive single dose of JNJ-77474462 SC.
干预措施: JNJ-77474462 (Drug)
Cohort E: JNJ-77474462 IV (Wave 1)
Participants will receive single dose of JNJ-77474462 intravenously (IV).
干预措施: JNJ-77474462 (Drug)
Cohort G: JNJ-77474462 SC (Wave 2)
Participants will receive single dose of JNJ-77474462 SC.
干预措施: JNJ-77474462 (Drug)
Cohort H: JNJ-77474462 IV (Wave 2)
Participants will receive single dose of JNJ-77474462 IV.
干预措施: JNJ-77474462 (Drug)
Cohort J: Anakinra SC
Participants will receive a SC injection of anakinra once daily for 3 days.
干预措施: Anakinra (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of JNJ-77474462
时间窗: Up to Week 12
Cmax is the maximum observed plasma concentration.
Terminal Half-Life (T1/2) of JNJ-77474462
时间窗: Up to Week 12
T1/2 is defined as the time measured for the plasma concentration to decrease by 1 half of its original concentration.
Absolute Subcutaneous (SC) Bioavailability (F%)
时间窗: Up to Week 12
(F%) is defined as absolute SC bioavailability to be calculated using the following equation: AUC(0-infinity) SC/mean AUC(0-infinity) IV \* 100 percent (%).
Area Under the Plasma Concentration Versus Time Curve from Time Zero to Infinity with Extrapolation of the Terminal Phase (AUC[0-infinity]) of JNJ-77474462
时间窗: Up to Week 12
AUC(0-infinity) is defined as area under the plasma concentration versus time curve from time zero to infinity with extrapolation of the terminal phase of JNJ-77474462.
Area Under the Plasma 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 Week 12
AUC(0-last) is defined as area under the plasma concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration of JNJ-77474462.
次要结局
- Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG)(Up to Week 12)
- Number of Participants with Clinically Significant Changes in Vital Signs(Up to Week 12)
- Number of Participants with Anti-JNJ-77474462 Antibodies(Up to Week 12)
- Percentage of Participants with Treatment-emergent Adverse Events (TEAE)(Up to Week 12)
- Number of Participants with Clinically Significant Changes in Laboratory Findings(Up to Week 12)
- Percentage of Participants with Serious Adverse Events (SAE)(Up to Week 12)