Status:
ACTIVE_NOT_RECRUITING
A Study of KK4277 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus and Cutaneous Lupus Erythematosus
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Healthy Volunteers
Systemic Lupus Erythematosus (SLE)
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 tol...
Eligibility Criteria
Inclusion
- Part 1
- Voluntary written informed consent to participate in the study
- Japanese or non-Asian healthy men 18 to \< 50 years at the time of informed consent
- BMI 18.5 to \< 30.0 at screening
- 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
- Patients who meet the EULAR/ACR 2019 SLE classification criteria and have a diagnosis of SLE by screening
- Patients with CLE diagnosed by skin biopsy
Exclusion
- Part 1
- Current illness requiring treatment
- History of or current respiratory disease, heart disease, gastrointestinal disease, kidney disease, liver disease, psychiatric disease, autoimmune disease, or Cancer.
- History or of current drug allergy
Key Trial Info
Start Date :
August 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT05411016
Start Date
August 3 2022
End Date
December 1 2025
Last Update
September 19 2025
Active Locations (23)
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1
Fujita Health University Hospital
Kutsukake, Aichi-ken, Japan, 470-1192
2
Japan Community Health care Organization Chukyo Hospital
Minami, Aichi-ken, Japan, 457-8510
3
Juntendo University Urayasu Hospital
Urayasu, Chiba, Japan, 279-0021
4
Kyusyu University Hospital
Higashi, Fukuoka, Japan, 812-8582