Systemic Lupus Erythematosus
Conditions
Interventions
A single administration of AK1910
A single or repeated administration of AK1910
Sponsors
Shirae Shinichiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Japanese healthy men and women or Caucasian healthy men [2] Individuals >=18 to [1] Patients who meet the EULAR/ACR 2019 SLE classification criteria and have a diagnosis of SLE [2] Individuals >=18 years to < 75 years at the time of informed consent [3] Individuals who fully understand the details of the study and who are capable of providing written informed consent
Exclusion criteria
Exclusion criteria: [1] Past history of disease in organsystems considered unsuitable for this study [2] Past history of allergy or anaphylaxis to drugs or other substances [3] Other protocol defined exclusion criteria could apply [1] Patients with active central nervouslupus or systemic autoimmune diseases other than systemic lupus erythematosus [2] Patients with history or complications of serious diseases considered unsuitable for this study [3] Patients with history or complications of infections that may affect safety and efficacy evaluation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *Plasma concentration of compound(s) *Number of participants with adverse events | — |
Contacts
Public ContactClinical Trial Information Contact for
ASAHI KASEI THERAPEUTICS CORPORATION
Outcome results
None listed