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 |
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Health condition(s) or Problem(s) studied | Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus |
Date of first enrollment | 19/07/2022 |
Target sample size | 158 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | <Part 1> A single IV or SC administration of KK4277 <Part 2> Repeated IV administration of KK4277 |
Outcome(s)
Primary Outcome | Number of participants with adverse events |
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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 |
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Age maximum | < 75age old |
Gender | Both |
Include criteria | Part 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 criteria | Part 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
Primary Sponsor | Kinoshita Jun |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) |
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 |
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 |
clinical.info.jp@kyowakirin.com | |
Affiliation | Kyowa Kirin Co., Ltd. |