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

Phase 1

Recruiting

• Conditions: Systemic Lupus Erythematosus

• Registration Number: JPRN-jRCT2071230085
• Lead Sponsor: Sato Kumiko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-07
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

[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

[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

[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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
*Plasma concentration of compound(s)<br>*Number of participants with adverse events