[Translation] Phase Ib clinical study on human tolerance and pharmacokinetic/pharmacodynamics of pegylated recombinant human granulocyte-stimulating factor injection

1、考察实体瘤患者对ASK-101的耐受性及该药物的安全性； 2、考察ASK-101在实体瘤患者中的药代动力学及药效动力学特征； 3、初步观察ASK-101在实体瘤患者中的疗效； 4、为制定Ⅱ期临床研究给药方案提供依据。

[Translation]

1. To investigate the tolerance of patients with solid tumors to ASK-101 and the safety of the drug; 2. To investigate the pharmacokinetic and pharmacodynamic characteristics of ASK-101 in patients with solid tumors; 3. To preliminarily observe the efficacy of ASK-101 in patients with solid tumors; 4. To provide a basis for formulating the dosing regimen for Phase II clinical studies.

Start Date27 Apr 2018

Sponsor / Collaborator

Jiangsu Aosaikang Pharmaceutical Co. Ltd.

CTR20170827

/ RecruitingPhase 1

聚乙二醇化重组人粒细胞刺激因子注射液在中国健康受试者单次给药人体耐受性和PK／PD Ia 期临床研究

[Translation] Phase Ia clinical study on human tolerance and PK/PD of single-dose pegylated recombinant human granulocyte-stimulating factor injection in healthy Chinese subjects

观察单次皮下注射聚乙二醇化重组人粒细胞剌激因子注射液在中国健康受试者体内安全性和耐受性，探究健康人群单次给药最大耐受剂量（MTD）；评价单次皮下注射聚乙二醇化重组人粒细胞剌激因子注射液在中国健康受试者体内药代动力学（PK）特征／药效动力学（PD）特征。

[Translation]

To observe the safety and tolerability of a single subcutaneous injection of pegylated recombinant human granulocyte-stimulating factor injection in healthy Chinese subjects, and to explore the maximum tolerated dose (MTD) of a single dose in healthy people; to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of a single subcutaneous injection of pegylated recombinant human granulocyte-stimulating factor injection in healthy Chinese subjects.

Start Date31 Jul 2017

Sponsor / Collaborator

Jiangsu Aosaikang Pharmaceutical Co. Ltd.

CTRI/2009/091/001016

/ CompletedPhase 3

Randomized, comparative, Phase III clinical trial to compare the efficacy and safety of recombinant human pegylated granulocyte colony stimulating factor(Peg G-CSF) versus granulocyte colony stimulating factor (G-CSF) in subjects with nonmyeloid malignancies receiving myelosuppressive chemotherapy.

Start Date02 Feb 2010

Sponsor / Collaborator

Wockhardt Ltd.

100 Clinical Results associated with Pegylated recombinant human granulocyte colony stimulating factor( Jiangsu Aosaikang Pharmaceutical Co. Ltd.)

100 Translational Medicine associated with Pegylated recombinant human granulocyte colony stimulating factor( Jiangsu Aosaikang Pharmaceutical Co. Ltd.)

100 Patents (Medical) associated with Pegylated recombinant human granulocyte colony stimulating factor( Jiangsu Aosaikang Pharmaceutical Co. Ltd.)

100 Deals associated with Pegylated recombinant human granulocyte colony stimulating factor( Jiangsu Aosaikang Pharmaceutical Co. Ltd.)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Neutropenia	Phase 1	China	Jiangsu Aosaikang Pharmaceutical Co. Ltd.	31 Jul 2017

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASCO2020	Not Applicable	Lymphoma	178	PEG-rhG-CSF	ddtdtbfoth(fgicojxmmz) = kzbmutjdpn jhokxicpnx (nymkovqihv ) View more	Positive	25 May 2020
				rhG-CSF	ddtdtbfoth(fgicojxmmz) = jnkyawzkgr jhokxicpnx (nymkovqihv ) View more

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