Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Kyowa Kirin Co., Ltd.
Age
18–75
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Voluntary written informed consent to participate in the study
Japanese or non-Asian healthy men 18 to \< 50 years at the time of informed consent
BMI 18.5 to \< 30.0 at screening
Voluntary written informed consent to participate in the study
Age 18 years to \< 75 years at the time of informed consent
Weight over 40 kg and BMI 18.5 to \< 35.0 at screening
Patients who meet any of the following criteria
1. Patients who meet the EULAR/ACR 2019 SLE classification criteria and have a diagnosis of SLE by screening
2. Patients with CLE diagnosed by skin biopsy
You may not be if
Current illness requiring treatment
History of or current respiratory disease, heart disease, gastrointestinal disease, kidney disease, liver disease, psychiatric disease, autoimmune disease, or Cancer.
History or of current drug allergy
Complications of active lupus nephritis(urinary column (granular column or red blood cell column), hematuria (\>5 red blood cells/high power field, excluding other causes such as stones or infection), proteinuria \>0.5 g/24 h, pyuria (\>5 white blood cells/high power field excluding infection)) or active central nervous lupus (delirium, psychiatric symptoms, seizures, etc.)
Patients with serious complications that are judged by the investigator or sub-investigator to affect the conduct and evaluation of the study.
Patients with bacterial, viral, fungal, or parasitic infections recognized within 28 days prior to obtaining consent
Patients with an infectious disease requiring hospitalization or IV administration of antimicrobial, antiviral, antifungal, or antiparasitic drugs within 24 weeks prior to obtaining consent
