The main aim of this clinical trial is to assess the safety and tolerability of PN20 in adult patients with primary immune thrombocytopenia (ITP). The main questions it aims to answer are: * Is PN20 safe in these patients? * Could these patients potentially benefit from PN20 treatment? Participants will * Receive one subcutaneous injection of PN20 according to weight; * Visit the clinic for assessment.
This is a multicenter, open-label, single-arm, dose-escalation Phase1b study aimed at evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary efficacy of a single dose of PN20 in adult patients with primary immune thrombocytopenia (ITP). The trial is a dose escalation study, including Screening (no more than 14 days), Treatment (single dose) and the post-treatment follow-up (4 weeks). And the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of PN20 in ITP will be assessed in this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Three dose cohorts, single dose, subcutaneous injections
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
RECRUITINGThe Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
RECRUITINGJining First People's Hospital
Jining, Shandong, China
Adverse Event (AE)
The incidence of adverse events related to PN20.
Time frame: Treatment and post-treatment follow-up period (28 days after a single dose)
The percentage of subjects who reach the target therapeutic platelet level after administration
It is defined as the proportion of subjects whose platelet count reaches at least 2 times the baseline platelet count within 28 days after administration and is within the range of 50×10\^9/L to 450×10\^9/L (inclusive).
Time frame: Treatment and post-treatment follow-up period (28 days after a single dose)
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Hematology Hospital of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
RECRUITINGThe Second Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
RECRUITING