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| Name | Class |
|---|---|
| Suzhou Yasheng Pharmaceutical Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APG-2575 | Experimental | Dose escalation |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APG-2575 | Drug | Take orally once daily (QD) for 12 weeks. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number 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. | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) of APG-2575 in SLE patients. | To evaluate the metabolic characteristics of APG-2575 in SLE patients | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the number and percentages of immune cells clusters. | The changes of immune cell clusters from baseline. | Up to 1 year |
| Change in the number and percentages of cytokines. | The changes of cytokines from baseline. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yifan Zhai | Contact | 240-505-6608 | Yzhai@ascentage.com | |
| Xiaofeng Han | Contact | Xiaofeng.Han@ascentage.com |
| Name | Affiliation | Role |
|---|---|---|
| Sheng Chen, Ph.D | Renji Hospital Shanghai Jiaotong University School of Medical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital Shanghai Jiaotong University School of Medical | Recruiting | Shanghai | Shanghai Municipality | 200127 | China |
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| ID | Term |
|---|---|
| C000726452 | Lisaftoclax |
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| Other |
Take orally once daily (QD) for 12 weeks. |
|
To evaluate the metabolic characteristics of APG-2575 in SLE patients |
| 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 | 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. | Up to 1 year |
| Up to 1 year |