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A Study of KK4277 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus
Sponsor: Kyowa Kirin Co., Ltd.
Summary
Part 1 : To evaluate the safety and tolerability of a single intravenous (IV) or subcutaneous (SC) dose of KK4277 in healthy Japanese or non-Asian adult males. Part 2 : To evaluate the safety and tolerability of repeated IV or SC administration of KK4277 in patients with Systemic lupus erythematosus (SLE) or Cutaneous lupus erythematosus (CLE).
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
157
Start Date
2022-08-03
Completion Date
2025-12
Last Updated
2025-09-19
Healthy Volunteers
Yes
Interventions
Placebo
Placebo is administered single dose or multiple dose by IV or SC injection
KK4277
KK4277 is administered single dose or multiple dose by IV or SC injection
Locations (23)
Fujita Health University Hospital
Kutsukake, Aichi-ken, Japan
Japan Community Health care Organization Chukyo Hospital
Minami, Aichi-ken, Japan
Juntendo University Urayasu Hospital
Urayasu, Chiba, Japan
Kyusyu University Hospital
Higashi, Fukuoka, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Yokohama City University Medical Center
Minami, Kanagawa, Japan
Kitasato University Hospital
Minami, Kanagawa, Japan
National University Corporation Tohoku University Tohoku University Hospital
Aoba, Miyagi, Japan
Niigata University Medical & Dental Hospital
Chuo Ku, Niigata, Japan
University of the Ryukyus Hospital
Ginowan, Okinawa, Japan
Saitama Medical University Hospital
Moriyama, Saitama, Japan
Institute of Science Tokyo Hospital
Bunkyō-Ku, Tokyo, Japan
St. Luke's International Hospital
Chuo Ku, Tokyo, Japan
Showa Medical University East Hospital
Shinagawa-Ku, Tokyo, Japan
Keio University Hospital
Shinjuku-Ku, Tokyo, Japan
Japan Institute for Health Security National Center for Global Health and Medicine
Shinjuku-Ku, Tokyo, Japan
Medical Co. LTA Sumida Hospital
Sumida-ku, Tokyo, Japan
Fukushima Medical University Hospital
Fukushima, Japan
Nagasaki University Hospital
Nagasaki, Japan
Juntendo University Nerima Hospital
Tokyo, Japan
Wakayama Medical University Hospital
Wakayama, Japan
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, South Korea