Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus
Conditions
Interventions
A single IV or SC administration of KK4277
Repeated IV or SC administration of KK4277
Sponsors
Kinoshita Jun
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Part 1: - Voluntary written informed consent to participate in the study - Japanese or non-Asian healty 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 1. Patients who meet the EULAR/ACR 2019 SLE classification criteria and have a diagnosis of SLE by screening 2. Patients with CLE diagnosed by skin biopsy
Exclusion criteria
Exclusion criteria: 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 Cacer. - History or of current drug allergy Part2: - Complications of active lupus nephritis(urinary column (granular column or red blood cell column), hematuria (>5 red blood cells/high power field, excluding other causes such as stones or infection), proteinuria >0.5 g/24 h, pyuria (>5 white blood cells/high power field excluding infection)) or active central nervous lupus (delirium, psychiatric symptoms, seizures, etc.) - Patients with skin rashes (psoriasis, drug-induced lupus, sarcoidosis, etc.) that may affect safety and efficacy evaluation -Patients with bacterial, viral, fungal, or parasitic infections recognized within 28 days prior to obtaining consent -Patients with an infectious disease requiring hospitalization or IV administration of antimicrobial, antiviral, antifungal, or antiparasitic drugs within 24 weeks prior to obtaining consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| -Profile of pharmacokinetics of serum KK4277 concentration -Time to the maximum concentration -The maximum concentration -Area under the concentration-time curve | — |
Countries
Japan, Korea
Contacts
Public ContactClinical trial information contact
Kyowa Kirin Co., Ltd.
Outcome results
None listed