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Clinical Trials associated with PEGylated thrombopoietin(Chongqing Paijin Biotechnology Co Ltd)A Single-arm, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamics and Immunogenicity of PN20 for the Prevention of Chemotherapy-induced Thrombocytopenia in Patients With Lymphoma or Solid Tumor
The main aim of this clinical trial is to assess the safety and tolerability of PN20 in adult patients with chemotherapy-induced thrombocytopenia (CID). The main questions it aims to answer are:
* Is PN20 safe in these patients?
* Could these patients potentially benefit from PN20 prevention? Participants will
* Receive subcutaneous injections of PN20 according to weight on the first day of chemotherapy cycle, within 1 hour before the administration of chemotherapy drugs,
* Visit the clinic on Day 1 (D1), D2, D3, D4, D5, D8, D11, D13, D15 and D21 for assessment.
评价注射用聚乙二醇化促血小板生成肽(PN20) 在化疗所致血小板减少症患者中的单臂、开放标签、单次及多次给药剂量递增研究
[Translation] A single-arm, open-label, single- and multiple-dose escalation study evaluating pegylated thrombopoietic peptide for injection (PN20) in patients with chemotherapy-induced thrombocytopenia
主要目的:评价PN20用于成人CIT患者的安全性和耐受性,并通过单、多次给药探索合适的给药剂量及频次,确定Ⅱ期临床试验的推荐剂量和频次。
次要目的:①评价PN20在成人CIT患者中单、多次皮下注射给药的药效动力学、药代动力学及免疫原性特征;②评价PN20在成人CIT患者中的初步疗效。
[Translation] Primary objective: To evaluate the safety and tolerability of PN20 in adult CIT patients, and to explore the appropriate dosage and frequency of administration through single and multiple administrations, and determine the recommended dosage and frequency for Phase II clinical trials.
Secondary objectives: ① To evaluate the pharmacodynamics, pharmacokinetic and immunogenicity characteristics of PN20 in adult CIT patients after single and multiple subcutaneous injections; ② To evaluate the preliminary efficacy of PN20 in adult CIT patients.
A Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of PN20 in Healthy Adult Volunteers
The main aim of this clinical trial is to assess the safety of PN20 in healthy volunteers aged 18 to 50 years. The main questions it aims to answer are:
* Is PN20 safe in adult? Researchers will compare PN20 to a placebo (a look-alike substance that contains no drug) to see if PN20 is safe.
Participants will
* Receive a single dose injection of PN20 or placebo according to weight,
* Stay in hospital for assessment.
100 Clinical Results associated with PEGylated thrombopoietin(Chongqing Paijin Biotechnology Co Ltd)
100 Translational Medicine associated with PEGylated thrombopoietin(Chongqing Paijin Biotechnology Co Ltd)
100 Patents (Medical) associated with PEGylated thrombopoietin(Chongqing Paijin Biotechnology Co Ltd)
100 Deals associated with PEGylated thrombopoietin(Chongqing Paijin Biotechnology Co Ltd)