About this trial
his study is a randomized, double-blinded, and placebo-controlled phase Ia clinical study in subjects with SLE. The study is designed to assess the safety and tolerability of IASO-782 for the treatment of SLE.
Eligibility criteria
Qualifiers
Aged 18 to 75 years;
Clinically confirmed diagnosis of SLE before screening;
Currently receiving standard treatment regimens, including any single drug or combination of drugs;
Organ function or laboratory test is basically normal;
Disqualifiers
History of other primary malignant neoplasm within 5 years of screening;
A history of cardiac disease within the recent 3 months, including New York Heart Association (NYHA) Class III/IV congestive heart failure and cardiac arrhythmias requiring drug treatment;
Subjects with poorly controlled hypertension despite drug treatment;
A history of hypersensitivity to any component of the study drug or its excipients confirmed before screening;
Trial design
Treatments tested in this trial
- IASO-782 injection
- Placebo