Pegylated synthetic human c-peptide(Pegylated synthetic human c-peptide) - 药物靶点：C-peptide x NGF_专利_临床

概要

基本信息

药物类型

合成多肽

别名

C-peptide long-acting、Ersatta、PEGylated C-peptide

+ [3]

靶点

C-peptide x NGF

作用机制

C-peptide 调节剂(Connecting peptide modulators)、NGF刺激剂(神经生长因子刺激剂)、Adenosine triphosphatase stimulants

治疗领域

免疫系统疾病神经系统疾病内分泌与代谢疾病

在研适应症-

非在研适应症

1型糖尿病糖尿病周围神经病变

原研机构

Cebix, Inc.

在研机构-

非在研机构

Cebix, Inc.

最高研发阶段无进展临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

登录后查看时间轴

序列信息

Sequence Code 63678

关联

2

项与 Pegylated synthetic human c-peptide 相关的临床试验

NCT01681290 / Completed临床2期

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of CBX129801 (Ersatta™), Long-Acting Synthetic C-Peptide, in Type 1 Diabetes Mellitus Subjects With Mild to Moderate Diabetic Peripheral Neuropathy

The purpose of the study is to determine the beneficial effects of CBX129801 (PEGylated synthetic human C-peptide) following weekly subcutaneous administration for 12 months in type 1 diabetes mellitus patients (T1DM) with mild to moderate diabetic peripheral neuropathy (DPN).

开始日期2012-10-01

申办/合作机构

Cebix, Inc.

NCT01293461 / Completed临床1/2期

A Randomized, Blinded, Placebo-Controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of CBX129801 (Long-Acting Synthetic C-Peptide) After Subcutaneous Administration in Patients With Type 1 Diabetes Mellitus

The purpose of this study is to assess safety and tolerability and determine the pharmacokinetics of subcutaneous single and multiple (up to 12) dose administration of CBX129801 (long-acting synthetic C-peptide) in type 1 diabetes patients.

开始日期2011-04-01

申办/合作机构

Cebix, Inc.

100 项与 Pegylated synthetic human c-peptide 相关的临床结果

登录后查看更多信息

100 项与 Pegylated synthetic human c-peptide 相关的转化医学

登录后查看更多信息

100 项与 Pegylated synthetic human c-peptide 相关的专利（医药）

登录后查看更多信息

8

项与 Pegylated synthetic human c-peptide 相关的文献（医药）

2020-06-01·Arthroscopy: The Journal of Arthroscopic & Related Surgery1区 · 医学

Microfractures Versus a Porcine-Derived Collagen-Augmented Chondrogenesis Technique for Treating Knee Cartilage Defects: A Multicenter Randomized Controlled Trial

1区 · 医学

Article

作者: Chang, Chong Bum ; Wang, Joon Ho ; Song, In Soo ; Yoo, Jae Doo ; Chon, Je-Gyun ; Choi, Nam Yong ; Chun, Churl Hong ; Kang, Seung-Baik ; Kim, Jin Goo ; Ha, Jeong Ku ; In, Yong ; Kim, Myung Ku ; Kim, Man Soo ; Moon, Chan Woong

PURPOSEThe purpose of this study was to evaluate the clinical efficacy and safety of treating patients with a cartilage defect of the knee with microfractures and porcine-derived collagen-augmented chondrogenesis technique (C-ACT).METHODSOne hundred participants were randomly assigned to the control group (n = 48, microfracture) or the investigational group (n = 52, C-ACT). Clinical and magnetic resonance imaging (MRI) outcomes were assessed 12 and 24 months postoperatively for efficacy and adverse events. Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) assessment was used to analyze cartilage tissue repair. MRI outcomes for 50% defect filling and repaired tissue/reference cartilage (RT/RC) ratio were quantified using T2 mapping. Clinical outcomes were assessed using the visual analogue scale (VAS) for pain and 20% improvement, minimal clinically important difference (MCID), and patient acceptable symptom state for Knee Injury and Osteoarthritis Outcome Score (KOOS) and the International Knee Documentation Committee score.RESULTSMOCART scores in the investigation group showed improved defect repair and filling (P = .0201), integration with the border zone (P = .0062), and effusion (P = .0079). MRI outcomes showed that the odds ratio (OR) for ≥50% defect filling at 12 months was statistically higher in the investigation group (OR 3.984, P = .0377). Moreover, the likelihood of the RT/RC OR becoming ≥1 was significantly higher (OR 11.37, P = .0126) in the investigation group. At 24 months postoperatively, the OR for the VAS 20% improvement rate was significantly higher in the investigational group (OR 2.808, P = .047). Twenty-three patients (52.3%) in the control group and 35 (77.8%) in the investigation group demonstrated more than the MCID of KOOS pain from baseline to 1 year postoperatively, with a significant difference between groups (P = .0116).CONCLUSIONIn this multicenter randomized trial, the addition of C-ACT resulted in better filling of cartilage defect of the knee joint.LEVEL OF EVIDENCELevel Ⅰ, Multicenter Randomized Controlled Trial.

2016-04-01·Diabetes Care1区 · 医学

Long-Acting C-Peptide and Neuropathy in Type 1 Diabetes: A 12-Month Clinical Trial

1区 · 医学

Article

作者: Foyt, Howard ; Wahren, John ; Arezzo, Joseph C. ; Daniels, Mark

OBJECTIVELack of C-peptide in type 1 diabetes may be an important contributing factor in the development of microvascular complications. Replacement of native C-peptide has been shown to exert a beneficial influence on peripheral nerve function in type 1 diabetes. The aim of this study was to evaluate the efficacy and safety of a long-acting C-peptide in subjects with type 1 diabetes and mild to moderate peripheral neuropathy.RESEARCH DESIGN AND METHODSA total of 250 patients with type 1 diabetes and peripheral neuropathy received long-acting (pegylated) C-peptide in weekly dosages of 0.8 mg (n = 71) or 2.4 mg (n = 73) or placebo (n = 106) for 52 weeks. Bilateral sural nerve conduction velocity (SNCV) and vibration perception threshold (VPT) on the great toe were measured on two occasions at baseline, at 26 weeks, and at 52 weeks. The modified Toronto Clinical Neuropathy Score (mTCNS) was used to grade the peripheral neuropathy.RESULTSPlasma C-peptide rose during the study to 1.8–2.2 nmol/L (low dose) and to 5.6–6.8 nmol/L (high dose). After 52 weeks, SNCV had increased by 1.0 ± 0.24 m/s (P < 0.001 within group) in patients receiving C-peptide (combined groups), but the corresponding value for the placebo group was 1.2 ± 0.29 m/s. Compared with basal, VPT had improved by 25% after 52 weeks of C-peptide therapy (Δ for combined C-peptide groups: −4.5 ± 1.0 μm, placebo group: −0.1 ± 0.9 μm; P < 0.001). mTCNS was unchanged during the study.CONCLUSIONSOnce-weekly subcutaneous administration of long-acting C-peptide for 52 weeks did not improve SNCV, other electrophysiological variables, or mTCNS but resulted in marked improvement of VPT compared with placebo.

2015-07-01·International Journal of Toxicology4区 · 医学

A 9-Month Toxicity and Toxicokinetic Assessment of Subcutaneous Pegylated Human C-peptide (CBX129801) in Cynomolgus Monkeys

4区 · 医学

Article

作者: Kousba, Ahmed ; Naas, Dennis ; Morris, Teresa ; Mazzoni, Michelle

C-peptide is formed in the biosynthesis of insulin and is therefore deficient in patients with type 1 diabetes mellitus. A pegylated form of human synthetic C-peptide (CBX129801) has been developed to extend the half-life of the native peptide and is undergoing clinical investigation as replacement therapy to treat diabetic peripheral neuropathy. This monkey study was conducted to evaluate the toxicity of CBX129801 with weekly subcutaneous dosing for 39 weeks at dose levels of 0 (vehicle), 0.4, 1.33, and 4.0 mg/kg/wk. No systemic adverse effects were observed at any dose with maximal CBX129801 plasma concentrations of 735 to 1050 nmol/L during the dosing period (physiological range is 1-3 nmol/L). CBX129801-related effects were limited to minimal macrophagic vacuolization at the injection sites and in the associated draining (axillary) lymph nodes; these local effects largely resolved by the end of a 7-week recovery period. No systemic macrophagic vacuolization was observed. Additionally, there was no histological evidence for plaque formation in the major arteries of these nondiabetic animals.

100 项与 Pegylated synthetic human c-peptide 相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16283

研发状态

10 条进展最快的记录,

登录

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
1型糖尿病	临床2期	美国	Cebix, Inc.	2012-10-01
1型糖尿病	临床2期	瑞典	Cebix, Inc.	2012-10-01
1型糖尿病	临床2期	加拿大	Cebix, Inc.	2012-10-01
糖尿病周围神经病变	临床前	美国	Cebix, Inc.	2012-10-01
糖尿病周围神经病变	药物发现	瑞典	Cebix, Inc.	2012-10-01
糖尿病周围神经病变	药物发现	加拿大	Cebix, Inc.	2012-10-01

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01681290 (Pubmed \| Diabetes Care)	临床2期	1型糖尿病	250	Long-acting C-peptide 0.8 mg	衊夢襯壓廠築鏇願鑰衊(願齋積願淵遞齋範願網) = 齋壓餘繭鏇鹹觸鏇構窪築醖製艱築願願蓋願構 (製顧鏇夢鹹遞齋鬱構網 ) 更多	-	2016-04-01
				Long-acting C-peptide 2.4 mg	衊夢襯壓廠築鏇願鑰衊(願齋積願淵遞齋範願網) = 鏇襯艱夢繭衊範構網網築醖製艱築願願蓋願構 (製顧鏇夢鹹遞齋鬱構網 ) 更多