JPRN-jRCT2071210082进行中（未招募）1 期
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 ParticipantsNOTE: Official Title should have no more than 240 characters.
akano Masayoshi0 个研究点目标入组 32 人开始时间: 2021年10月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 60age old（—）
- 性别
- All
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 antiinflammatory
- •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
研究者
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