To evaluate the safety, tolerability, pharmacokinetics and pharmacokinetics of multi-dose APG-2575 in mild-to-moderate systemic lupus erythematosus (SLE).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Renji Hospital Shanghai Jiaotong University School of Medical
Shanghai, Shanghai Municipality, China
RECRUITINGNumber of participants with treatment-related adverse events as assessed by CTCAE v5.0.
According to CTCAE v5.0, the number and frequency of adverse events of test drug were assessed.
Time frame: Up to 1 year
Peak Plasma Concentration (Cmax) of APG-2575 in SLE patients.
To evaluate the metabolic characteristics of APG-2575 in SLE patients
Time frame: At Day1 and Day 28 since the first dose of study drug.
Area under the plasma concentration versus time curve (AUC) of APG-2575 in SLE patients.
To evaluate the metabolic characteristics of APG-2575 in SLE patients
Time frame: At Day1 and Day 28 since the first dose of study drug.
Time to Peak (Tmax) of APG-2575 in SLE patients.
To evaluate the metabolic characteristics of APG-2575 in SLE patients
Time frame: At Day1 and Day 28 since the first dose of study drug.
Assessment of SLE disease activity using SLEDAI（Systemic Lupus Erythematosus Disease Activity Index）-2000.
To evaluate the patients' efficacy.
Time frame: Up to 1 year
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