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JAPANESE
国立保健医療科学院
JRCT ID: jRCT2071220015

Registered date:12/06/2022

A study of KK4277 in Healthy Volunteers, Patient with Systemic Lupus Erythematosus, and Patient with Cutaneous Lupus Erythematosus

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedSystemic Lupus Erythematosus, Cutaneous Lupus Erythematosus
Date of first enrollment19/07/2022
Target sample size157
Countries of recruitmentKorea,Japan
Study typeInterventional
Intervention(s)<Part 1> A single IV or SC administration of KK4277 <Part 2> Repeated IV or SC administration of KK4277

Outcome(s)

Primary OutcomeNumber of participants with adverse events
Secondary Outcome-Profile of pharmacokinetics of serum KK4277 concentration -Time to the maximum concentration -The maximum concentration -Area under the concentration-time curve

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum< 75age old
GenderBoth
Include criteriaPart 1: - 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 Part 2: - 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
Exclude criteriaPart 1: - 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 Part2: - 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

Related Information

Contact

Public contact
Name Clinical trial information contact
Address 1-9-2, Otemachi, Chiyoda-ku, Tokyo Tokyo Japan 100-0004
Telephone +81-3-5205-7200
E-mail clinical.info.jp@kyowakirin.com
Affiliation Kyowa Kirin Co., Ltd.
Scientific contact
Name Jun Kinoshita
Address 1-9-2, Otemachi, Chiyoda-ku, Tokyo Tokyo Japan 100-0004
Telephone +81-3-5205-7200
E-mail clinical.info.jp@kyowakirin.com
Affiliation Kyowa Kirin Co., Ltd.