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A Study of APG-2575 in Patients With Mild-to-moderate Systemic Lupus Erythematosus.

RECRUITINGPhase 1/2Sponsored by Ascentage Pharma Group Inc.
Actively Recruiting
PhasePhase 1/2
SponsorAscentage Pharma Group Inc.
Started2024-08-09
Est. completion2026-04
Eligibility
Age18 Years – 65 Years
SexFEMALE
Healthy vol.Accepted

Summary

To evaluate the safety, tolerability, pharmacokinetics and pharmacokinetics of multi-dose APG-2575 in mild-to-moderate systemic lupus erythematosus (SLE).

Eligibility

Age: 18 Years – 65 YearsSex: FEMALEHealthy volunteers accepted
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.

Conditions2

LupusSLE

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