JPRN-jRCT2031210359进行中(未招募)1 期
A Phase 1, Randomized, Participant- and Investigator-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3541860 in Healthy Japanese and Non-Japanese Participants - J3K-MC-KIAA
Wakayama Naohiko0 个研究点目标入组 90 人开始时间: 2021年10月2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
- 90
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 <= 65age old(—)
- 性别
- All
入选标准
- •Are male or female not of childbearing potential
- •- Have a body weight between 18 and 32 kilograms per square meter (kg/m2) and a body weight >=50 kilograms (kg)
- •- Have veins suitable for blood sampling
排除标准
- •- Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
- •- Have active or latent TB
- •- Have had breast cancer within the past 10 years or had lymphoma, leukemia, or any malignancy within the past 5 years
- •- Show clinical evidence of syphilis, HIV, hepatitis C, or hepatitis B, and/or test positive
- •- Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.
- •- Have previously completed a clinical trial investigating any other molecule targeting CD19, CD20 or have previously discontinued from this study after receiving LY3541860
- •- Are currently participating in or completed a clinical trial within the last 30 days
- •- Have received a vaccine containing a live (attenuated) virus within 28 days of screening or intend to receive during the course of the study.
研究者
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