Overview
To evaluate the safety, tolerability, pharmacokinetics and pharmacokinetics of multi-dose APG-2575 in mild-to-moderate systemic lupus erythematosus (SLE).
Description
This is a randomized, double-blind, placebo-controlled Phase I/II study. About 40 participants will be recruited to receive either APG-2575 or a placebo, with doses from 200mg up to 800mg.
Eligibility
Inclusion Criteria:
- 1\. Diagnosis of systemic lupus erythematosus for at least 6 months.
- 2\. On stable treatment for systemic lupus erythematosus before first dose at least 28 days.
- 3\. SLEDIA-2000 score: 4-12
- 4.Other than systemic lupus erythematosus, subject should be in general good health.
Exclusion Criteria:
- 1\. Severe systemic lupus erythematosus.
- 2\. Significant autoimmune disease other than lupus.
- 3\. Significant, uncontrolled or unstable disease in any organ.
