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.

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Contacts and locations

Locations

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499, South Korea

  • Fujita Health University Hospital

    Kutsukake, Aichi-ken, 470-1192, Japan

  • Fukushima Medical University Hospital

    Fukushima, 960-1295, Japan

  • Institute of Science Tokyo Hospital

    Bunkyō-Ku, Tokyo, 113-8519, Japan

  • Japan Community Health care Organization Chukyo Hospital

    Minami, Aichi-ken, 457-8510, Japan

  • Japan Institute for Health Security National Center for Global Health and Medicine

    Shinjuku-Ku, Tokyo, 162-8655, Japan

  • Juntendo University Nerima Hospital

    Tokyo, 177-8521, Japan

  • Juntendo University Urayasu Hospital

    Urayasu, Chiba, 279-0021, Japan

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641, Japan

  • Keio University Hospital

    Shinjuku-Ku, Tokyo, 160-8582, Japan

  • Kitasato University Hospital

    Minami, Kanagawa, 252-0375, Japan

  • Kyusyu University Hospital

    Higashi, Fukuoka, 812-8582, Japan

  • Medical Co. LTA Sumida Hospital

    Sumida-ku, Tokyo, 130-0004, Japan

  • Nagasaki University Hospital

    Nagasaki, 852-8501, Japan

  • National University Corporation Tohoku University Tohoku University Hospital

    Aoba, Miyagi, 980-8574, Japan

  • Niigata University Medical & Dental Hospital

    Chuo Ku, Niigata, 951-8520, Japan

  • Saitama Medical University Hospital

    Moriyama, Saitama, 350-0495, Japan

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Showa Medical University East Hospital

    Shinagawa-Ku, Tokyo, 142-0054, Japan

  • St. Luke's International Hospital

    Chuo Ku, Tokyo, 104-8560, Japan

  • University of the Ryukyus Hospital

    Ginowan, Okinawa, 901-2725, Japan

  • Wakayama Medical University Hospital

    Wakayama, 641-8510, Japan

  • 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.

cutaneous lupus erythematosus systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.