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ACTIVE NOT RECRUITING
NCT05411016
PHASE1

A Study of KK4277 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus

Sponsor: Kyowa Kirin Co., Ltd.

View on ClinicalTrials.gov

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

DRUG

Placebo

Placebo is administered single dose or multiple dose by IV or SC injection

DRUG

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