Phase I Study of AK1910 in Healthy Japanese Subjects, Healthy Caucasian Subjects, Patients with Systemic Lupus Erythematosus (Single Dose and Multiple Dose Study)

Sato Kumiko0 个研究点目标入组 120 人开始时间: 2023年11月7日最近更新: 2023年11月20日

适应症

试验速览

暂无简介。

•[1] Japanese healthy men and women or Caucasian healthy men
•[2] Individuals >=18 to <45 years of age at the time of informed consent
•[3] Individuals who fully understand the details of the study and who are capable of providing written informed consent
•[1] Patients who meet the EULAR/ACR 2019 SLE classification criteria and have a diagnosis of SLE
•[2] Individuals >=18 years to < 75 years at the time of informed consent
•[3] Individuals who fully understand the details of the study and who are capable of providing written informed consent

•[1] Past history of disease in organsystems considered unsuitable for this study
•[2] Past history of allergy or anaphylaxis to drugs or other substances
•[3] Other protocol defined exclusion criteria could apply
•[1] Patients with active central nervouslupus or systemic autoimmune diseases other than systemic lupus erythematosus
•[2] Patients with history or complications of serious diseases considered unsuitable for this study
•[3] Patients with history or complications of infections that may affect safety and efficacy evaluation

发起方

Sato Kumiko