The main aim of this clinical trial is to assess the safety and efficacy of a single dose of PN20 in treatment of thrombocytopenia in adult patients with chronic liver disease undergoing an elective procedure. The main questions it aims to answer are: * How effective is PN20 in treating thrombocytopenia in patients with chronic liver disease? * Is PN20 safe in these patients? Participants will * Receive a single subcutaneous injections of PN20 or placebo according to weight before an elective procedure, * Visit the clinic for assessment.
This is aan open-label, single-dose, dose-escalation phase Ib/II study conducted in two stages, Phase Ib and Phase II, designed to evaluate the safety, tolerability, efficacy, PK, PD, and immunogenicity of PN20 in patients with CLDT in patients with CLDT. Phase Ib stage is an open-label, single-dose, dose-escalation study. Three dose levels (8 participants per group) will be administered sequentially from low to high. Phase 2 stage is a randomized, double-blind, single-dose, placebo-controlled study. Eligible patients are randomized in a 1:1 ratio to the treatment or placebo group following informed consent. The dosing regimen in the treatment group is selected based on the Phase Ib results, with one or two dose levels selected. If two PN20 dose levels are selected, randomization follows a 1:1:1 ratio to one of the two treatment groups or to the placebo group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
54
Capital Medical University Affiliated Beijing Ditan Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGThe Eighth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGHenan Provincial People's Hospital
Zhengzhou, Henan, China
RECRUITINGZhenjiang Third People's Hospital
Zhenjiang, Jiangsu, China
RECRUITINGJilin University First Hospital
Changchun, Jilin, China
RECRUITINGLiaocheng People's Hospital
Chaozhou, Shandong, China
RECRUITINGQingdao Municipal Hospital
Qingdao, Shandong, China
RECRUITINGThe proportion of responders
Based on the results of hematology tests, calculate the proportion of participants whose platelet counts remained ≥50×10⁹/L from 24 hours pre-surgery through 7 days post-surgery without requiring rescue treatment for bleeding.
Time frame: 8 days (from 24 hours pre-surgery through 7 days post-surgery)
Adverse Events
Incidence and severity of all adverse events related to PN20 observed through vital signs, physical examinations, 12-lead ECGs, clinical laboratory tests (including hematology, urinalysis, blood chemistry, coagulation function, and pregnancy tests for women of childbearing potential)
Time frame: From dosing of PN20 (Day 1) to Day 28
Cmax
Maximum Plasma Concentration
Time frame: From pre-dose to 8 days after dosing
AUC
Area Under the Plasma Concentration-time Curve
Time frame: From pre-dose to 8 days after dosing
Immunogenicity of PN20
Using a validated ELISA assay to detect ADAs against the thrombopoietic peptide and polyethylene glycol
Time frame: From pre-dose to 28 days after dosing
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