Study of Safety and Efficacy of HS-10542 in Patients With Paroxysmal Nocturnal Hemoglobinuria
NCT07470762 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-04-13
Summary
This was a phase 1b/2,open label, multi-center study to assess efficacy and safety of HS-10542 in adulte patients with paroxysmal nocturnal hemoglobinuria (PNH) with signs of active hemolysis.
Conditions
Interventions
- DRUG
-
HS-10542
HS-10542 low dose,QD
- DRUG
-
HS-10542
HS-10542 high dose, QD
- DRUG
-
HS-10542
Orally QD ,The recommended dose from Ph1b
Sponsors & Collaborators
-
Jiangsu Hansoh Pharmaceutical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-14
- Primary Completion
- 2027-05-30
- Completion
- 2029-07-31
Countries
- China
Study Locations
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