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研究主要目的：研究健康成人、HE受试者和NT1受试者接受TAK-861单次和/或多次口服给药的安全性和耐受性。研究次要目的：研究健康成人接受TAK-861混悬剂和/或片剂单次和/或多次口服给药的PK。研究HE受试者和NT1受试者接受TAK-861片剂多次口服给药的PK。评估食物对TAK-861片剂PK的影响。

开始日期2023-06-21

申办/合作机构

Spera Pharma, Inc.初创企业

[+2]

CTR20230147 / Completed临床2期

一项在持续性/慢性原发性免疫性血小板减少症患者中评价TAK-079的安全性、耐受性和有效性的II期、随机、双盲、安慰剂对照研究

主要目的主要目的是评价TAK-079在持续性/慢性原发性免疫性血小板减少症(ITP)患者中的安全性和耐受性次要目的：次要目的是评估TAK-079对持续性/慢性原发性ITP患者血小板计数的影响探索性目的： 1. 确定TAK-079的PK 2. 确定TAK-079的药效学特征 3. 探索血小板应答的持久性 4. 确定TAK-079对血小板相关抗体水平和亚型的影响 5. 需要补救治疗的患者频率和比例 6. 使用ITP出血评分进行出血评估 7. 确定治疗对健康相关生活质量的影响 8. 探索疫苗诱导的保护性抗体 9. 探索TAK-079重复给药对抗药物抗体（ADA）和疾病活动度的探索性生物标志物的影响

开始日期2023-05-31

申办/合作机构

武田（中国）国际贸易有限公司

[+2]

CTR20222215 / Active, not recruiting临床1期

一项在原发性IgA 肾病患者中评价Mezagitamab（TAK-079）联合稳定背景治疗的安全性、耐受性、药代动力学和有效性的Ib 期、多中心、开放性研究

主要目的: 评价Mezagitamab 在接受稳定背景治疗的原发性IgAN 患者中的安全性和耐受性。次要目的：确定Mezagitamab 的PK， PD 特征，对蛋白尿的影响和免疫原性。

开始日期2022-12-18

申办/合作机构

Takeda Development Center Americas, Inc.

[+2]

100 项与 Spera Pharma, Inc. 相关的临床结果

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0 项与 Spera Pharma, Inc. 相关的专利（医药）

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8

项与 Spera Pharma, Inc. 相关的文献（医药）

2024-06-01·Journal of Natural Medicines

Photoreaction products of extract from the fruiting bodies of Polyozellus multiplex

Article

作者: Koyama, Kiyotaka ; Kinoshita, Kaoru ; Sasaki, Hiroaki ; Shimizu, Emi ; Yamaguchi, Takamasa ; Nakai, Keiyo ; Otsuka, Hayato ; Yamano, Mitsuhisa

Photochemical reactions are powerful tools for synthesizing organic molecules. The input of energy provided by light offers a means to produce strained and unique molecules that cannot be assembled using thermal protocols, allowing for the production of immense molecular complexity in a single chemical step. Furthermore, unlike thermal reactions, photochemical reactions do not require active reagents such as acids, bases, metals, or enzymes. Photochemical reactions play a central role in green chemistry. This article reports the isolation and structure determination of four new compounds (1-4) from the photoreaction products of the Polyozellus multiplex MeOH ext. The structures of the new compounds were elucidated using MS, IR, comprehensive NMR measurements and microED. The four compounds were formed by deacetylation of polyozellin, the main secondary metabolite of P. multiplex, and addition of singlet oxygen generated by sunlight. To develop drugs for treating Alzheimer's disease (AD) on the basis of the amyloid cascade hypothesis, the compounds (1-4) obtained by photoreaction were evaluated for BACE1 inhibitory activity. The hydrolysates (5 and 6) of polyozellin, the main secondary metabolites of P. multiplex, were also evaluated. The photoreaction products (3 and 4) and hydrolysates (5 and 6) of polyozellin showed BACE1 inhibitory activity (IC₅₀: 2.2, 16.4, 23.3, and 5.3 μM, respectively).

2022-07-01·AAPS PharmSciTech

Gastroretentive Sustained-Release Tablets Combined with a Solid Self-Micro-Emulsifying Drug Delivery System Adsorbed onto Fujicalin®

Article

作者: Omachi, Yoshihiro

Gastroretentive drug delivery systems (GRDDS) get retained in the stomach for a long time, thus facilitating the absorption of drugs in the upper gastrointestinal tract. However, drugs that are difficult to dissolve or unstable in an acidic environment are not suitable for GRDDS. The current study designs GRDDS combined with a self-micro-emulsifying drug delivery system (SMEDDS) for drugs with solubility or stability problems in the stomach. The model drug fenofibrate was formulated into the optimized liquid SMEDDS composed of 50 w/w% Capryol^® PGMC, 40 w/w% Kolliphor^® RH40, and 10 w/w% Transcutol^® HP and solidified through adsorption on several porous adsorbents. In a dissolution medium at pH 1.2, the powdered SMEDDS using Fujicalin^® dissolved quickly and achieved higher drug dissolution than other adsorbents. Based on these results, a gastroretentive bilayer tablet consisting of a drug release layer and a swelling layer was designed. The drug release layer was formulated with the powdered SMEDDS and hydroxypropyl methylcellulose (HPMC) as a release modifier. HPMC was also added to the swelling layer as a water-swellable polymer. The dissolution rate depended on the viscosity of the HPMC in the drug release layer. The time for 90% drug release was extended from 3.7 to 12.0 h by increasing the viscosity grade of HPMC from 0.1 to 100 K. Moreover, the tablet swelled and maintained a size comparable to a human pylorus diameter or more for at least 24 h. This GRDDS could apply to a broader range of drug candidates.

Peptide Science

Design, synthesis and antiangiogenic activity of the vitamin D binding protein-macrophage activating factor(DBP-maf)-derived synthetic peptide

作者: Fujita, Shuji ; Tsuruyama, Ai ; Chiba, Kazuhiro ; Matsuura, Nariaki ; Kono, Yusuke ; Hori, Hitoshi ; Nagano, Tomio ; Onizuka, Shinya ; Nakata, Eiji ; Uto, Yoshihiro

A symposium report.A vitamin D-binding protein macrophage activating factor (DBP-maf) is a glycoprotein with its antiproliferative activity for endothelial cells and antiangiogenicity observed in the chick chorioallantoic membrane assay.The authors designed and synthesized DBP-maf-derived synthetic peptides to determine key functional region of DBP-maf.The authors present the synthesis and antiproliferative activities of these DBP-maf mimic peptides with or without GalNAc on their Thr residue.

100 项与 Spera Pharma, Inc. 相关的药物交易

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100 项与 Spera Pharma, Inc. 相关的转化医学

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药物(靶点)	适应症	全球最高研发状态

Mezagitamab ( CD38 )	血小板减少症更多	临床2期
Soticlestat ( CH24H )	癫痫更多	临床2期
TAK-676 ( STING )	实体瘤更多	临床1期
Suntinorexton ( OX2R )	发作性睡病1型更多	临床1期
Firazorexton ( OX2R )	发作性睡病更多	终止