A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose or Multiple Ascending Dose Study of KK4277 in Healthy Volunteers, Patient with Systemic Lupus Erythematosus, and Patient with Cutaneous Lupus Erythematosus

Kinoshita Jun0 个研究点目标入组 158 人开始时间: 2022年6月12日最近更新: 2023年10月17日

试验速览

暂无简介。

•- Voluntary written informed consent to participate in the study
•- Japanese or non-Asian healty 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

•- Current illness requiring treatment
•- History of or current respiratory disease, heart disease, gastrointestinal disease, kidney disease, liver disease, psychiatric disease, autoimmune disease, or Cacer.
•- 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 skin rashes (psoriasis, drug-induced lupus, sarcoidosis, etc.) that may affect safety and efficacy evaluation
•-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

发起方

Kinoshita Jun