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XH-S003

Phase 2

PNH - Paroxysmal Nocturnal Hemoglobinuria | Small Molecules | Other |Infinity Pharmaceuticals, Inc.|Trials Updated: May 18, 2025

XH-S003 target and mechanism

ModalitySmall Molecules

Also known as XH-S003 Capsule

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

XH-S003 clinical trials

XH-S003 · 1 trial · 1 indication

Phase 2 1
NCT06978699A Phase II Study Evaluating the Efficacy and Safety of XH-S003 Capsules in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)PNH - Paroxysmal Nocturnal Hemoglobinuria
RECRUITING24 Analytics
PHASE2RECRUITING
A Phase II Study Evaluating the Efficacy and Safety of XH-S003 Capsules in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
PNH - Paroxysmal Nocturnal Hemoglobinuria
NCT0697869924
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Study Endpoints

Primary Endpoints

Changes of hemoglobin compared with baseline
8 weeks

Secondary Endpoints

Proportion of subjects with an increase in Hb ≥20g/L compared with baseline (without RBC transfusion);
8 weeks
Changes in Indirect Bilirubin compared to baseline;
8 weeks
Changes in reticulocyte counts compared to baseline;
8 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose 1EXPERIMENTALOnce daily
Dose 2EXPERIMENTALOnce daily
Dose 3EXPERIMENTALOnce daily

Interventions

NameTypeDescription
XH-S003 CapsuleDRUG25mg \& 100mg
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female with aged ≥18 years old; * Weight ≥40 kg and BMI≥18 kg/m2 ; * Diagnosed with PNH: with red blood cell or granulocyte clone levels \>10% detected by flow cytopy within 6 months prior to screening or during screening; * Patients who have not previously received an...

Countries:China
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