A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ-75105186 in Healthy Japanese Participants and a Single Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ-75105186 in Healthy Chinese Participants
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Part 1 and 2: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of JNJ-75105186 after single ascending oral dose administration in healthy Japanese participants and after single oral dose administration in healthy Chinese participants.
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population. This determination must be recorded in the participant's source documents and initialed by the investigator
- •Healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel including liver enzymes, other specific tests, blood coagulation, 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
- •Body weight not less than 50 kilograms (kg) and body mass index within the range 18 to 30 kg per meter square (kg/m^2) (inclusive)
- •A woman must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for at least 90 days after receiving the administration of study intervention
- •Must sign an informed consent form (ICF) indicating they understand the purpose of, and procedures required for, the study and is willing to participate in the study
- •It is recommended that participants are up to date on age-appropriate vaccinations prior to screening as per routine local medical guidelines. For study participants who received locally-approved (and including emergency use-authorized) Coronavirus Disease of 2019 (COVID-19) vaccines recently prior to study entry, follow applicable local vaccine labeling, guidelines, and standards of care for participants receiving immune-targeted therapy when determining an appropriate interval between vaccination and study enrollment
排除标准
- •Had major surgery, (example, requiring general anesthesia) within 3 months before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study or within 12 weeks after the last dose of study intervention administration
- •History of surgical resection of the stomach, small or large intestine (excluding appendectomy, cholecystectomy, or resection of benign polyps)
- •History of bleeding associated with procedures such as endoscopy or phlebotomy; or use of medications such as nonsteroidal anti-inflammatory drugs or aspirin within 28 days prior to screening or planned use during the study
- •Preplanned surgery or procedures that would interfere with the conduct of the study
- •Clinically significant infection within 30 days prior to screening or any serious infection within 6 months prior to screening requiring intravenous antimicrobial therapy
研究组 & 干预措施
Part 1: Single Ascending Dose (SAD) Cohorts
Healthy Japanese participants will receive JNJ-75105186 or matching placebo orally in Cohorts 1-3.
干预措施: JNJ-75105186 (Drug)
Part 1: Single Ascending Dose (SAD) Cohorts
Healthy Japanese participants will receive JNJ-75105186 or matching placebo orally in Cohorts 1-3.
干预措施: Placebo (Other)
Part 2: Single Dose (SD) Cohort
Healthy Chinese participants will receive JNJ-75105186 or matching placebo orally in Cohort 4.
干预措施: JNJ-75105186 (Drug)
Part 2: Single Dose (SD) Cohort
Healthy Chinese participants will receive JNJ-75105186 or matching placebo orally in Cohort 4.
干预措施: Placebo (Other)
结局指标
主要结局
Part 1 and 2: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: Up to 6 weeks
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.
Part 1 and 2: Plasma Concentration of JNJ-75105186
时间窗: Predose up to 48 hours postdose (up to Day 3)
Plasma samples will be analyzed to determine concentrations of JNJ-75105186 using a validated, specific and sensitive method.
次要结局
未报告次要终点