A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of QY101 Ointment in Patients With Plaque Psoriasis

The goal of this clinical trial is to evaluate the effectiveness of QY101 ointment in adult patients with plaque psoriasis (2-20% BSA).

Start Date17 May 2023

Sponsor / Collaborator

E-Nitiate Biopharmaceuticals Hangzhou Co. Ltd.

CTR20230730 / RecruitingPhase 2

评价QY101软膏在斑块状银屑病患者中有效性和安全性的一项多中心、随机、双盲、安慰剂对照的II期临床试验

[Translation] A multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the efficacy and safety of QY101 ointment in patients with plaque psoriasis

这是一项随机、双盲、多中心、安慰剂对照的II期临床试验，旨在评价QY101软膏在斑块状银屑病成年患者中的有效性、安全性。主要目的为：在斑块状银屑病成年患者中（2~20%BSA），评价QY101软膏的有效性。次要目的：在斑块状银屑病成年患者中（2~20% BSA），评价QY101 软膏的安全性。

[Translation]

This is a randomized, double-blind, multicenter, placebo-controlled Phase II clinical trial designed to evaluate the efficacy and safety of QY101 ointment in adult patients with plaque psoriasis. The primary objective is to evaluate the efficacy of QY101 ointment in adult patients with plaque psoriasis (2-20% BSA). The secondary objective is to evaluate the safety of QY101 ointment in adult patients with plaque psoriasis (2-20% BSA).

Start Date15 May 2023

Sponsor / Collaborator

E-Nitiate Biopharmaceuticals Hangzhou Co. Ltd.

CTR20221309 / CompletedPhase 1

QY101软膏在中国健康受试者中的随机、双盲、安慰剂对照Ⅰ期临床研究

[Translation] A randomized, double-blind, placebo-controlled phase I clinical study of QY101 ointment in healthy Chinese subjects

观察在中国健康成年受试者中单次和多次外用QY101软膏的安全性、耐受性。考察单次和多次外用QY101软膏在中国健康成年受试者体内的药代动力学特征。

[Translation]

To observe the safety and tolerability of single and multiple external use of QY101 ointment in healthy Chinese adult subjects. To investigate the pharmacokinetic characteristics of single and multiple external use of QY101 ointment in healthy Chinese adult subjects.

Start Date15 Jun 2022

Sponsor / Collaborator

E-Nitiate Biopharmaceuticals Hangzhou Co. Ltd.

100 Clinical Results associated with QY101

100 Translational Medicine associated with QY101

100 Patents (Medical) associated with QY101

Literatures (Medical) associated with QY101

01 May 2003·Sheng wu hua xue yu sheng wu wu li xue bao Acta biochimica et biophysica Sinica

[Purification and characterization of alginate lyase from marine bacterium Vibrio sp. QY101].

Article

Author: Han, Feng ; Han, Wen-Jun ; Yu, Wen-Gong ; Song, Kai ; Li, Jing-Bao

Extracellular alginate lyase secreted by Vibrio sp. QY101, which was isolated from brown algae, was purified to homogeneity by a combination of ammonium sulfate precipitation, DEAE-Sepharose Fast Flow anion-exchange chromatography and Superdex 75 gel filtration chromatography. Its molecular mass was 39 kD as determined by SDS-PAGE analysis. The enzyme had an optimal temperature of 30 degrees for its activity, and was most active at pH 7.5. The thermal and pH stability were 0-30 degrees, and pH 6.5-8.5, respectively. The enzyme activity was stimulated by 0.5 mol/L NaCl, 1.0 mmol/L Ca(2+) or 5.0 mmol/L (Mn(2+), and inhibited by 5.0 mmol/L Ni(2+), 1.0 mmol/L Fe2+) or 1.0 mmol/L EDTA. Preliminary analysis on substrate specificity showed that this alginate lyase had activity on both poly-alpha 1,4-L-guluronate and poly-beta1,4-D-mannuronate substrates.

PLoS ONEQ3 · CROSS-FIELD

Antibiofilm Activity of an Exopolysaccharide from Marine Bacterium Vibrio sp. QY101

Q3 · CROSS-FIELD

ArticleOA

Author: Jingbao Li ; Yuchao Gu ; Gaofei Duan ; Peng Jiang ; Xinzhi Lu ; Feng Han ; Wengong Yu

Bacterial exopolysaccharides have always been suggested to play crucial roles in the bacterial initial adhesion and the development of complex architecture in the later stages of bacterial biofilm formation. However, Escherichia coli group II capsular polysaccharide was characterized to exert broad-spectrum biofilm inhibition activity. In this study, we firstly reported that a bacterial exopolysaccharide (A101) not only inhibits biofilm formation of many bacteria but also disrupts established biofilm of some strains. A101 with an average molecular weight of up to 546 KDa, was isolated and purified from the culture supernatant of the marine bacterium Vibrio sp. QY101 by ethanol precipitation, iron-exchange chromatography and gel filtration chromatography. High performance liquid chromatography traces of the hydrolyzed polysaccharides showed that A101 is primarily consisted of galacturonic acid, glucuronic acid, rhamnose and glucosamine. A101 was demonstrated to inhibit biofilm formation by a wide range of Gram-negative and Gram-positive bacteria without antibacterial activity. Furthermore, A101 displayed a significant disruption on the established biofilm produced by Pseudomonas aeruginosa, but not by Staphylococcus aureus. Importantly, A101 increased the aminoglycosides antibiotics' capability of killing P. aeruginosa biofilm. Cell primary attachment to surfaces and intercellular aggregates assays suggested that A101 inhibited cell aggregates of both P. aeruginosa and S. aureus, while the cell-surface interactions inhibition only occurred in S. aureus, and the pre-formed cell aggregates dispersion induced by A101 only occurred in P. aeruginosa. Taken together, these data identify the antibiofilm activity of A101, which may make it potential in the design of new therapeutic strategies for bacterial biofilm-associated infections and limiting biofilm formation on medical indwelling devices. The found of A101 antibiofilm activity may also promote a new recognition about the functions of bacterial exopolysaccharides.

100 Deals associated with QY101

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Plaque psoriasis	Phase 2	CN	E-Nitiate Biopharmaceuticals Hangzhou Co. Ltd.	15 May 2023
Dermatitis, Atopic	IND Approval	CN	E-Nitiate Biopharmaceuticals Hangzhou Co. Ltd.	19 Apr 2022

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