Systemic Lupus Erythematosus
Conditions
Brief summary
A study of CM313 in subjects with systemic lupus erythematosus
Detailed description
This is a multi-center, randomed, open-label, dose escalation and dose expansion, Phase 1 study to evaluate the safety, tolerability, Pharmacokinetics and preliminary anti-tumor activity. About 40 patients who meet eligibility criteria will be randomized 4:1 to receive either CM313 or matched placebo, intravenous infusion. The treatment period includes single dosing and multiple dosing period, in which CM313 and placebo will be adminitrated intravenously, once every 1 week.
Interventions
BIOLOGICALCM313 2 mg/kg
Once 1 week, intravenous infusion.
BIOLOGICALCM313 4 mg/kg
Once 1 week, intravenous infusion.
BIOLOGICALCM313 8 mg/kg
Once 1 week, intravenous infusion.
BIOLOGICALCM313 16 mg/kg
Once 1 week, intravenous infusion.
BIOLOGICALPlacebo
Once 1 week, intravenous infusion.
Sponsors
Keymed Biosciences Co.Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs). | Baseline up to Day 113 | Safety parameters |
Outcome results
None listed