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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.
This study is a multiple-dose escalation study in subjects with SLE. The study is designed to enroll subjects with SLE. This study will evaluate the safety and preliminary dose range of IASO-782 in subjects with SLE at the following dose levels:4mg/kg,6mg/kg and 10mg/kg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Drug:IASO-782 injection Dosage and Administration: single dose of IASO-782,4mg/kg ,6 mg/kg or 10 mg/kg , intravenous injection at day 1,day 8 and day15. |
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| Control group | Placebo Comparator | Drug:placebo Dosage and Administration: single dose of placebo, intravenous injection at day 1,day 8 and day 15. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IASO-782 injection | Drug | Each subject will be given only one dose of IASO-782. Subjects should avoid strenuous exercise within 48 h before administration and remain seated or semi-recumbent (except for necessary activities) for 4 h after administration. IASO-782 solution for injection or placebo was diluted in 0.9% sodium chloride injection (corresponding to the dose administered according to the body weight at baseline and the dose group) with a total volume of 250 mL, administered as a single intravenous drip at a drip rate recommended by the drug manual on the day of administration, The infusion time is about 90 minutes (± 15 minutes). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as assessed by CTCAE v6.0 | The safety and tolerability of IASO-782 will be assessed primarily by summarizing treatment-emergent AEs and SAEs. | up to 25 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Placebo | Drug | Each subject will be given one dose of placebo. Subjects should avoid strenuous exercise within 48 h before administration and remain seated or semi-recumbent (except for necessary activities) for 4 h after administration. IASO-782 solution for injection or placebo was diluted in 0.9% sodium chloride injection (corresponding to the dose administered according to the body weight at baseline and the dose group) with a total volume of 250 mL, administered as a single intravenous drip at a drip rate recommended by the drug manual on the day of administration, The infusion time is about 90 minutes (± 15 minutes). |
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