Phase I Study of AK1910 in Healthy Japanese Subjects, Healthy Caucasian Subjects, Patients with Systemic Lupus Erythematosus (Single Dose and Multiple Dose Study)

JRCT ID: jRCT2071230085

Registered date:07/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Systemic Lupus Erythematosus
• Date of first enrollment: 08/11/2023
• Target sample size: 120
• Study type: Interventional

Intervention(s)

<Part 1>
A single administration of AK1910
<Part 2>
A single or repeated administration of AK1910

Outcome(s)

Primary Outcome

*Plasma concentration of compound(s)
*Number of participants with adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

<Part 1>
[1] Japanese healthy men and women or Caucasian healthy men
[2] Individuals >=18 to <45 years of age 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
<Part 2>
[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

Exclude criteria

<Part 1>
[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
<Part 2>
[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

Related Information

• Primary Sponsor: Shirae Shinichiro