A Randomized, Double-blind, Placebo-controlled Phase I/II Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of APG-2575 in Patients With Mild-to-moderate Systemic Lupus Erythematosus.
Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
To evaluate the safety, tolerability, pharmacokinetics and pharmacokinetics of multi-dose APG-2575 in mild-to-moderate systemic lupus erythematosus (SLE).
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Renji Hospital Shanghai Jiaotong University School of Medical
RECRUITING
Shanghai
Contact Information
Primary
Yifan Zhai
Yzhai@ascentage.com
240-505-6608
Backup
Xiaofeng Han
Xiaofeng.Han@ascentage.com
Time Frame
Start Date: 2024-08-09
Estimated Completion Date: 2026-12
Participants
Target number of participants: 40
Treatments
Experimental: APG-2575
Dose escalation
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Ascentage Pharma Group Inc.
Collaborators: Suzhou Yasheng Pharmaceutical Co., Ltd.