A Study of CM313 Injection in Subjects With Systemic Lupus Erythematosus
Sponsored by Keymed Biosciences Co.Ltd
About this trial
Last updated 3 years ago
Study ID
CM313-106001
Status
Not yet recruiting
Type
Interventional
Phase
Phase 1/Phase 2
Placebo
Yes
Accepting
18 to 65 Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 2 years ago
What is this trial about?
A study of CM313 in subjects with systemic lupus erythematosus
What are the participation requirements?
Inclusion Criteria
- 18 years old ≤ age ≤ 65 years old.
- Positive autoantibody serology test at screening.
- Contraception.
- Voluntarily sign the ICF.
Exclusion Criteria
- With central nervous system disease caused by or not caused by SLE within 8 weeks before the first dose of study drug.
- Possibly active Mycobacterium tuberculosis infection.
- With the history of vital organ transplantation or hematopoietic stem cell/or bone marrow transplantation.
- Heavy drinking in the 3 months prior to screening.
- With depression or suicidal thoughts.