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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| KK4277 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo is administered single dose or multiple dose by IV or SC injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | For adverse events that occurred after administration of the investigational drug, number of subjects with AEs and occurrence frequency are evaluated. | Part 1 : from Day 1 through at most Day 113, Part 2: from Day 1 through at most Day 169 |
| Measure | Description | Time Frame |
|---|---|---|
| Profile of pharmacokinetics of serum KK4277 concentration | Part 1 : Day 1 (pre-dose, 0, 1, 6 hours after the start of administration), 2, 3, 4, 5, 6, 8, 15, 22, 29, 43, 57, 71, 85, 99, 113, Part 2 :Enrollment, Day1, 8, 15, 29, 43, 57, 71, 85, 99, 113, 141, 169 | |
| Time to the maximum concentration |
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Inclusion Criteria: Part 1
Inclusion Criteria: 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
Exclusion Criteria: Part 1
Exclusion Criteria:Part2
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| Name | Affiliation | Role |
|---|---|---|
| Jun Kinoshita | Kyowa Kirin Co., Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fujita Health University Hospital | Kutsukake | Aichi-ken | 470-1192 | Japan | ||
| Japan Community Health care Organization Chukyo Hospital |
The datasets generated and/or analyzed during the study sponsored by Kyowa Kirin will be available in the Vivli repository, https://vivli.org/ourmember/kyowa-kirin/ as long as conditions of data disclosure specified in the policy section of the Vivli website are satisfied.
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Outcomes Assessor: pharmacokinetic person, pharmacodynamic analysis person and investigational drug administration person are unblinded.
| KK4277 |
| Drug |
KK4277 is administered single dose or multiple dose by IV or SC injection |
|
| Part 1 : Day 1 to Day 113, Part 2 : Day 1 to Day 169 |
| The maximum concentration | Part 1 : Day 1 to Day 113, Part 2 : Day 1 to Day 169 |
| Area under the concentration-time curve | Part 1 : Day 1 to Day 113, Part 2 : Day 1 to Day 169 |
| Minami |
| Aichi-ken |
| 457-8510 |
| Japan |
| Juntendo University Urayasu Hospital | Urayasu | Chiba | 279-0021 | Japan |
| Kyusyu University Hospital | Higashi | Fukuoka | 812-8582 | Japan |
| Kanazawa University Hospital | Kanazawa | Ishikawa-ken | 920-8641 | Japan |
| Yokohama City University Medical Center | Minami | Kanagawa | 232-0024 | Japan |
| Kitasato University Hospital | Minami | Kanagawa | 252-0375 | 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 |
| University of the Ryukyus Hospital | Ginowan | Okinawa | 901-2725 | Japan |
| Saitama Medical University Hospital | Moriyama | Saitama | 350-0495 | Japan |
| Institute of Science Tokyo Hospital | Bunkyō-Ku | Tokyo | 113-8519 | Japan |
| St. Luke's International Hospital | Chuo Ku | Tokyo | 104-8560 | Japan |
| Showa Medical University East Hospital | Shinagawa-Ku | Tokyo | 142-0054 | Japan |
| Keio University Hospital | Shinjuku-Ku | Tokyo | 160-8582 | Japan |
| Japan Institute for Health Security National Center for Global Health and Medicine | Shinjuku-Ku | Tokyo | 162-8655 | Japan |
| Medical Co. LTA Sumida Hospital | Sumida-ku | Tokyo | 130-0004 | Japan |
| Fukushima Medical University Hospital | Fukushima | 960-1295 | Japan |
| Nagasaki University Hospital | Nagasaki | 852-8501 | Japan |
| Juntendo University Nerima Hospital | Tokyo | 177-8521 | Japan |
| Wakayama Medical University Hospital | Wakayama | 641-8510 | Japan |
| Ajou University Hospital | Suwon | Gyeonggi-do | 16499 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D008178 | Lupus Erythematosus, Cutaneous |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012871 | Skin Diseases |
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