A Randomised, Double-blind, Three-period Crossover Trial to Investigate the Safety and the Pharmacokinetic, Pharmacodynamic Characteristics of Two BioChaperone® Glucagon Formulations Compared to Marketed GlucaGen® in Subjects With Type 1 Diabetes

This is a single centre, double-blind, randomised, three-period crossover phase 1 trial in subjects with type 1 diabetes mellitus (T1DM). Each subject will be randomly allocated to a sequence of three treatments, i.e. two single subcutaneous doses of BioChaperone® Glucagon (BC Glucagon) formulation 1, BioChaperone® Glucagon formulation 2 and GlucaGen® HypoKit®, each at the fixed doses of 50 µg and 1 mg on 3 separate dosing visits.
Following trial drug administration, pharmacokinetics (PK) and pharmacodynamics (PD) assessments will be carried until 4 hours. Safety will be assessed during all the trial period.
The total trial maximum duration for the individual subject will be up to 10 weeks.

开始日期2017-06-06

申办/合作机构

Adocia SA

100 项与 BioChaperone Glucagon 相关的临床结果

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100 项与 BioChaperone Glucagon 相关的转化医学

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100 项与 BioChaperone Glucagon 相关的专利（医药）

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1,880

项与 BioChaperone Glucagon 相关的文献（医药）

2025-01-01·Combinatorial Chemistry & High Throughput Screening

Exploring Asthma Mechanism of Belamcanda Chinensis by “Dose–effect Weighted Coefficient” Network Pharmacology and Experiment Validation

Article

作者: Shen, Jiaming ; Wang, Yuelong ; Gao, Xiaochen ; Zhang, Nanxi ; Li, Chunnan ; Sun, Jiaming ; Lv, Jingwei ; Zhang, Kaiyue

Background:Asthma is a chronic inflammatory disease of the airways that seriously endangers human health. Belamcanda chinensis (BC), a traditional Chinese medicine, has been used to counteract asthma as it has been shown to possess anti-inflammatory and regulatory immunity properties.Objective:The study aimed to investigate the mechanisms of action of BC in the treatment of asthma; a “dose–effect weighted coefficient” network pharmacology method was established to predict potential active compounds.Methods:Information on the components and content of BC was obtained by UPLC-QEOrbitrap- MS spectrometry. Based on BC content, oral bioavailability, and molecular docking binding energy, dose-effect weighting coefficients were constructed. With the degree greater than average as the index, a protein–protein interaction (PPI) database was used to obtain the core key targets for asthma under dose–effect weighting. GO function and KEGG pathway analyses of the core targets were performed using DAVID software. Finally, MTT and ELISA assays were used to assess the effects of active components on 16HBE cell proliferation.Results:The experimental results using the 16HBE model demonstrated BC to have a potential protective effect on asthma. Network pharmacology showed SYK, AKT1, and ALOX5 to be the main key targets, and Fc epsilon RI as the promising signaling pathway. Eight components, such as tectoridin, mangiferin, luteolin, and isovitexin were the main active compounds, Finally, we analyzed the LPS-induced 16HBE proliferation of each active ingredient. Based on the activity verification study, all five predicted components promoted the proliferation of 16HBE cells. These five compounds can be used as potential quality markers for asthma.Conclusion:This study provides a virtual and practical method for the simple and rapid screening of active ingredients in natural products.

2024-11-01·Nutrition Reviews

Nutritional and health effects of bovine colostrum in neonates

Review

作者: Zhang, Min ; Zhou, Ping ; Zhang, Lian ; Luo, Fangmei

AbstractHigh concentrations of immunoglobulins, bioactive peptides, and growth factors are found in bovine colostrum (BC), the milk produced by cows in the first few days after parturition. Various biological functions make it increasingly used to provide nutritional support and immune protection to the offspring of many species, including humans. These biological functions include cell growth stimulation, anti-infection, and immunomodulation. The primary components and biological functions of colostrum were reviewed in the literature, and the authors also looked at its latent effects on the growth and development of neonates as well as on conditions such as infections, necrotizing enterocolitis, short bowel syndrome, and feeding intolerance. The importance of BC in neonatal nutrition, immune support, growth and development, and gut health has been demonstrated in a number of experimental and animal studies. BC has also been shown to be safe at low doses without adverse effects in newborns. BC supplementation has been shown to be efficient in preventing several disorders, including rotavirus diarrhea, necrotizing enterocolitis, and sepsis in animal models of prematurity and some newborn studies. Therefore, BC supplementation should be considered in cases where maternal milk is insufficient or donor milk is unavailable. The optimal age, timing, dosage, and form of BC administration still require further investigation.

2024-07-01·Journal of the Science of Food and Agriculture

Effects of bacterial cellulose/thyme essential oil emulsion coating on the shelf life of chilled chicken meat

Article

作者: Lyu, Yunbin ; Xu, Yuelong ; Xin, Jiajin ; Zhang, Chong

AbstractBACKGROUNDBacterial cellulose (BC) is a fiber substance produced by microbial fermentation. It is widely used in the food preservation industry because of its extremely pure texture, high crystallinity and high biocompatibility. In the present study, bacterial cellulose/thyme essential oil (BC/TEO‐E) with antibacterial and fresh‐keeping functions was prepared by ultrasonic treatment of modified bacterial cellulose for encapsulation of thyme essential oil, which effectively inhibited the spoilage of chilled chicken.RESULTSThe purified BC, produced by Acetobacter xylinum ATCC 53524, was ultrasonically treated wih different times (0, 30, 60 and 90 min). Transmission electron microscopy, scanning electron microscopy, Fourier transformed infrared spectroscopy, X‐ray diffraction, differential scanning calorimetry and zeta potential were used to characterize the structure of BC after ultrasound, showing that BC, treated for 30 min, had the optimal fiber structure, crystallinity (85.8%), thermal stability (347.77 °C) and solution stability (−26.63 ± 1.96 mV). BC/TEO‐E was prepared by a homogenizer for the preservation of chilled chicken. Optical microscopy indicated that the BC/TEO‐E prepared by 0.5% BC had optimal dispersion and stability, and even no delamination was observed in the emulsion. Compared with other groups (control, 0.5% BC and Tween‐E), the total number of colonies and coliforms in chilled chicken treated with 0.5% BC/TEO‐E was the lowest during the whole storage period (12 days), indicating that it can effectively inhibit bacterial growth. In addition, total volatile base nitrogen (TVB‐N), thiobarbituric acid reactive substances, pH and drip loss results showed that 0.5% BC/TEO‐E could effectively inhibit the spoilage of chilled chicken compared to the other treatment groups.CONCLUSIONAll of the results acquired in the present study indicate that BC/TEO‐E has a potential application in chilled chicken preservation. © 2024 Society of Chemical Industry.

100 项与 BioChaperone Glucagon 相关的药物交易

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