[Translation] A randomized, parallel, open, positive-controlled phase II clinical trial to evaluate the pharmacokinetics, safety and efficacy of octreotide long-acting injection in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NET)

主要目的：评估SYHX2008治疗GEP-NET患者的有效性。次要目的： 1) 评估SYHX2008治疗GEP-NET患者的类癌症状等其他疗效指标； 2）评估SYHX2008治疗GEP-NET患者的安全性； 3) 评估SYHX2008治疗GEP-NET患者的药代动力学特征；探索性目的：评估药代动力学与疗效或肿瘤标志物之间的相关性。

[Translation]

Primary purpose: To evaluate the efficacy of SYHX2008 in the treatment of GEP-NET patients. Secondary purpose: 1) To evaluate other efficacy indicators such as carcinoid symptoms in the treatment of GEP-NET patients with SYHX2008; 2) To evaluate the safety of SYHX2008 in the treatment of GEP-NET patients; 3) To evaluate the pharmacokinetic characteristics of SYHX2008 in the treatment of GEP-NET patients; Exploratory purpose: To evaluate the correlation between pharmacokinetics and efficacy or tumor markers.

Start Date30 Jul 2024

Sponsor / Collaborator

CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.

CTR20240239 / CompletedPhase 1

奥曲肽长效注射液在中国健康受试者中不同给药部位及与注射用醋酸奥曲肽微球的PK/PD对比研究

[Translation] A comparative PK/PD study of octreotide long-acting injection at different administration sites and octreotide acetate microspheres for injection in Chinese healthy subjects

主要目的：比较中国健康受试者在不同给药部位皮下注射奥曲肽长效注射液的相对生物利用度（bioavailability, BA）；比较中国健康受试者奥曲肽长效注射液和注射用醋酸奥曲肽微球单次给药后的药代动力学特征。次要目的：评价中国健康受试者不同给药部位皮下注射奥曲肽长效注射液的药效动力学（PD）特征；比较中国健康受试者奥曲肽长效注射液和注射用醋酸奥曲肽微球单次给药后的药效动力学（PD）特征；评价中国健康受试者注射奥曲肽长效注射液和注射用醋酸奥曲肽微球后的安全性和耐受性。

[Translation]

Primary objectives: To compare the relative bioavailability (BA) of octreotide long-acting injection in Chinese healthy subjects after subcutaneous injection at different administration sites; To compare the pharmacokinetic characteristics of octreotide long-acting injection and octreotide acetate microspheres for injection after single administration in Chinese healthy subjects. Secondary objectives: To evaluate the pharmacodynamic (PD) characteristics of octreotide long-acting injection in Chinese healthy subjects after subcutaneous injection at different administration sites; To compare the pharmacodynamic (PD) characteristics of octreotide long-acting injection and octreotide acetate microspheres for injection after single administration in Chinese healthy subjects; To evaluate the safety and tolerability of octreotide long-acting injection and octreotide acetate microspheres for injection in Chinese healthy subjects.

Start Date02 Mar 2024

Sponsor / Collaborator

CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.

CTR20230271 / CompletedPhase 1

评价奥曲肽长效注射液在中国健康受试者中单次给药的安全性、耐受性、药代动力学和药效学特征的Ⅰ期临床试验

[Translation] A phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of octreotide long-acting injection in healthy Chinese subjects

主要研究目的：评价奥曲肽长效注射液在中国健康受试者中单次给药的安全性、耐受性。次要研究目的：评价奥曲肽在中国健康受试者中单次皮下注射给药的药代动力学（PK）特征。评价奥曲肽在中国健康受试者中单次皮下注射给药的药效动力学（PD）特征。

[Translation]

Main study objectives: To evaluate the safety and tolerability of a single dose of octreotide long-acting injection in healthy Chinese subjects. Secondary study objectives: To evaluate the pharmacokinetic (PK) characteristics of octreotide after a single subcutaneous injection in healthy Chinese subjects. To evaluate the pharmacodynamic (PD) characteristics of octreotide after a single subcutaneous injection in healthy Chinese subjects.

Start Date02 Mar 2023

Sponsor / Collaborator

CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.

100 Clinical Results associated with Octreotide(CSPC Zhongqi)

100 Translational Medicine associated with Octreotide(CSPC Zhongqi)

100 Patents (Medical) associated with Octreotide(CSPC Zhongqi)

100 Deals associated with Octreotide(CSPC Zhongqi)

External Link

KEGG	Wiki	ATC	Drug Bank
D11204	-	-	DB00104

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Gastro-Enteropancreatic Neuroendocrine Tumor	Phase 2	CN	CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.	30 Jul 2024
Acromegaly	Phase 2	CN	CSPC Zhongqi Pharmaceutical Technology Shijiazhuang Co., Ltd.	30 Jan 2024

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