New lupus drug candidate KK4277 enters first safety tests in humans
NCT ID NCT05411016
First seen Nov 01, 2025 · Last updated Jun 23, 2026 · Updated 31 times
Summary
This early-stage trial is testing a new drug called KK4277 to see if it is safe for people with lupus. The study first gives a single dose to healthy volunteers, then multiple doses to patients with systemic lupus erythematosus (SLE) or cutaneous lupus erythematosus (CLE). Researchers are monitoring for side effects and how the drug moves through the body. This is a Phase 1 study, so it is too early to know if the drug will actually help treat lupus.
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Contacts and locations
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Locations
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Ajou University Hospital
Suwon, Gyeonggi-do, 16499, South Korea
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Fujita Health University Hospital
Kutsukake, Aichi-ken, 470-1192, Japan
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Fukushima Medical University Hospital
Fukushima, 960-1295, Japan
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Institute of Science Tokyo Hospital
Bunkyō-Ku, Tokyo, 113-8519, Japan
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Japan Community Health care Organization Chukyo Hospital
Minami, Aichi-ken, 457-8510, Japan
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Japan Institute for Health Security National Center for Global Health and Medicine
Shinjuku-Ku, Tokyo, 162-8655, Japan
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Juntendo University Nerima Hospital
Tokyo, 177-8521, Japan
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Juntendo University Urayasu Hospital
Urayasu, Chiba, 279-0021, Japan
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Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641, Japan
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Keio University Hospital
Shinjuku-Ku, Tokyo, 160-8582, Japan
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Kitasato University Hospital
Minami, Kanagawa, 252-0375, Japan
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Kyusyu University Hospital
Higashi, Fukuoka, 812-8582, Japan
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Medical Co. LTA Sumida Hospital
Sumida-ku, Tokyo, 130-0004, Japan
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Nagasaki University Hospital
Nagasaki, 852-8501, Japan
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National University Corporation Tohoku University Tohoku University Hospital
Aoba, Miyagi, 980-8574, Japan
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Niigata University Medical & Dental Hospital
Chuo Ku, Niigata, 951-8520, Japan
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Saitama Medical University Hospital
Moriyama, Saitama, 350-0495, Japan
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Seoul National University Hospital
Seoul, 03080, South Korea
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Showa Medical University East Hospital
Shinagawa-Ku, Tokyo, 142-0054, Japan
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St. Luke's International Hospital
Chuo Ku, Tokyo, 104-8560, Japan
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University of the Ryukyus Hospital
Ginowan, Okinawa, 901-2725, Japan
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Wakayama Medical University Hospital
Wakayama, 641-8510, Japan
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Yokohama City University Medical Center
Minami, Kanagawa, 232-0024, Japan
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
KK4277
What this could lead to
If this early trial shows KK4277 is safe, it could lead to larger studies testing whether it helps control lupus symptoms.
What could go wrong
This is a very early Phase 1 study focused on safety, not effectiveness. The drug may not work or could have side effects. Results in healthy people may not apply to lupus patients.
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.