A Phase II, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of LP-005 Injection in Patients With Paroxysmal Nocturnal Hemoglobinuria.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a multicenter, randomized, open-label, Phase II clinical study to evaluate the efficacy, safety, and pharmacokinetics of LP-005 injection in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Male or female, aged 18 to 65 years.
• Diagnosis of PNH based on flow cytometry with clone size \> 10% by granulocytes.
• Presence of one or more PNH-related signs or symptoms within 3 months prior to screening or a history of transfusion due to PNH.
• LDH level ≥2.0×upper limit of the normal range(ULN).
• Hemoglobin level \<100 g/L at screening.
Locations
Other Locations
China
The First Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Time Frame
Start Date: 2024-11-14
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 30
Treatments
Experimental: Cohort 1: LP-005 Dose 1
Experimental: Cohort 2: LP-005 Dose 2
Experimental: Cohort 3: LP-005 Dose 3
Related Therapeutic Areas
Sponsors
Leads: Longbio Pharma