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.

开始日期2023-12-06

申办/合作机构

重庆派金生物科技有限公司

CTR20233013 / Recruiting临床1期

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

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。

开始日期2023-12-05

申办/合作机构

重庆派金生物科技有限公司

NCT06523088 / Completed临床1期

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.

开始日期2022-06-16

申办/合作机构

重庆派金生物科技有限公司

100 项与聚乙二醇化促血小板生成肽(重庆派金生物科技有限公司) 相关的临床结果

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100 项与聚乙二醇化促血小板生成肽(重庆派金生物科技有限公司) 相关的转化医学

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100 项与聚乙二醇化促血小板生成肽(重庆派金生物科技有限公司) 相关的专利（医药）

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项与聚乙二醇化促血小板生成肽(重庆派金生物科技有限公司) 相关的文献（医药）

2004-07-01·Journal of Chromatography A2区 · 化学

Preparative and analytical chromatography of pegylated myelopoietin using monolithic media

2区 · 化学

Article

作者: David C Wood ; Troii Hall ; Christine E Smith

Monolithic media were compared with Q- and SP-Sepharose high performance chromatography for preparative purification and with Q- and SP-5PW chromatography for analysis of a pegylated form of myelopoietin (MPO), an engineered hematopoietic growth factor. The use of either monolithic or Sepharose based supports for preparative chromatography produced highly purified pegylated MPO with the monolithic media demonstrating peak resolution and repeatability at flow rates of 1 and 5 ml/min resulting in run times as much as five-fold shorter compared to Sepharose separations. The monolithic disks also resulted in 10-fold shorter run times for the analytical chromatography, however, their chromatographic profiles and peak symmetry were not as sharp compared to their Q-5PW and SP-5PW counterparts.

100 项与聚乙二醇化促血小板生成肽(重庆派金生物科技有限公司) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
血小板减少症	临床2期	中国	重庆派金生物科技有限公司	-
淋巴瘤	临床1期	中国	重庆派金生物科技有限公司	2023-12-06
实体瘤	临床1期	中国	重庆派金生物科技有限公司	2023-12-06
免疫性血小板减少症	临床1期	中国	重庆派金生物科技有限公司	2022-06-16
原发性血小板减少症	临床申请批准	中国	重庆派金生物科技有限公司	2024-06-04