[Translation] A dose-escalating multicenter clinical study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of intravitreal Y400 in patients with neovascular age-related macular degeneration (nAMD)

Ⅰ期：主要目的：评估nAMD受试者经单次或多次IVT注射Y400的安全性和耐受性，确定Y400的最大耐受剂量，并为2期研究推荐给药剂量（RP2D）。次要目的：评估nAMD受试者IVT单次和多次注射时Y400在全身的药代动力学特征（PK）；评估nAMD受试者IVT单次和多次注射Y400的初步疗效。探索目的：评估nAMD受试者IVT单次和多次注射Y400的免疫原性及其对Y400的PK、安全性的影响。 Ⅱ期：主要目的：与阿柏西普比较，评价Y400经IVT注射治疗nAMD的有效性和安全性，为后期进一步临床研究提出最佳剂量与给药方案。次要目的：评估Y400 IVT多次注射在全身的PK特征。探索目的：评估Y400的免疫原性及其潜在影响；探索Y400血液浓度与疗效的相关性（量效关系）。

[Translation]

Phase I: Primary objective: To evaluate the safety and tolerability of single or multiple IVT injections of Y400 in nAMD subjects, determine the maximum tolerated dose of Y400, and recommend the dose for Phase 2 study (RP2D). Secondary objective: To evaluate the pharmacokinetic characteristics (PK) of Y400 in the whole body during single and multiple IVT injections of nAMD subjects; to evaluate the preliminary efficacy of single and multiple IVT injections of Y400 in nAMD subjects. Exploratory objective: To evaluate the immunogenicity of single and multiple IVT injections of Y400 in nAMD subjects and its impact on the PK and safety of Y400. Phase II: Primary objective: To evaluate the efficacy and safety of Y400 in the treatment of nAMD by IVT injection compared with aflibercept, and to propose the optimal dose and dosing regimen for further clinical research in the later stage. Secondary objective: To evaluate the PK characteristics of multiple IVT injections of Y400 in the whole body. Exploratory objective: To evaluate the immunogenicity of Y400 and its potential impact; to explore the correlation between blood concentration of Y400 and efficacy (dose-effect relationship).

Start Date16 Aug 2023

Sponsor / Collaborator

Shenzhen Kangzhe Weisheng Pharmaceutical Development Co., Ltd.

ChiCTR2300072757 / SuspendedPhase 1/2IIT

Evaluation of the Safety, Tolerability, Pharmacokinetics, and Efficacy of Intravitreal Injection of Y400 in a Dose-Escalation Multicenter Clinical Study of Patients with Neovascular Age-Related Macular Degeneration (nAMD) in the Vitreous Cavity

Start Date30 Jun 2023

Sponsor / Collaborator-

100 Clinical Results associated with Y-400

100 Translational Medicine associated with Y-400

100 Patents (Medical) associated with Y-400

Literatures (Medical) associated with Y-400

01 Jun 2013·Hepatology internationalQ2 · MEDICINE

Probiotics promote rapid-turnover protein production by restoring gut flora in patients with alcoholic liver cirrhosis

Q2 · MEDICINE

Article

Author: Imaoka, Akemi ; Umezaki, Yoshinori ; Sata, Michio ; Ooeda, Kazutoshi ; Tamiya, Yoshitaka ; Ishibashi, Masahiko ; Koga, Hironori ; Nakano, Masatoshi ; Mitsuyama, Keiichi ; Hara, Taeko ; Matsumoto, Satoshi

BACKGROUND AND AIMS:

Accumulating evidence suggests that deterioration of the gut flora contributes to the pathogenesis of alcoholic liver cirrhosis (ALC). However, the ALC flora profile and its response to probiotic treatment have not been fully examined. This double-blind placebo-controlled study aimed to evaluate whether the probiotic beverage Yakult 400 (Y400), which contains Lactobacillus casei strain Shirota, improves liver function in ALC patients, and to analyze the precise gut flora profile by real-time quantitative PCR (qPCR).

METHODS:

A total of 37 hospitalized ALC patients were randomly allocated to Y400 (n = 18) and placebo (n = 19) groups. Y400 or placebo was served twice a day during the first half of the four-week study. Serum concentrations of rapid-turnover proteins (i.e., transthyretin and transferrin), hypersensitive C-reactive protein, and interleukin-6 were measured weekly. qPCR analysis of fecal bacteria was performed biweekly; stocked fecal samples from 46 healthy subjects were used as references.

RESULTS:

Serum transthyretin levels significantly increased in the Y400 group in week 3; similar-although statistically insignificant-increases were seen for transferrin and albumin. Levels of hypersensitive C-reactive protein, but not interleukin-6, significantly decreased in week 4. Before treatment, populations of obligate anerobic bacteria were significantly smaller and those of Enterobacteriaceae were larger in patients than in healthy subjects examined in a previous study. Y400 corrected this imbalance.

CONCLUSIONS:

This is the first report describing the unique gut flora of ALC patients. Y400 treatment normalized the gut flora and improved liver function. These promising findings warrant further investigation in larger, multicenter studies.

01 Jan 2004·Journal of veterinary scienceQ3 · AGRICULTURAL & FORESTRY SCIENCE

Immunomodulatory and antitumor effects in vivo by the cytoplasmic fraction of Lactobacillus casei and Bifidobacterium longum

Q3 · AGRICULTURAL & FORESTRY SCIENCE

ArticleOA

Author: Kim, Eun Hee ; Joo, Hong Gu ; Shin, Jung Gul ; Woo, Hee Jong ; Yim, In Been ; Kang, Hae Eun ; Lee, Jung Woo ; Kim, Ji Yeon

The immunomodulatory and antitumor effects of lactic acid bacteria (LABs) were investigated. Cytoplasmic fraction of Lactobacillus acidophilus, Lactobacillus casei and Bifidobacterium longum were tested for the antiproliferative activity in vitro to SNUC2A, SNU1, NIH/3T3 and Jurkat cell lines by crystal violet assay. All cytoplasmic fraction suppressed proliferation of tumor cells, though L. casei and B. longum were more effective. From these results, cytoplasmic fraction of L. casei and B. longum with Y400 as a control were administered as dietary supplements to Balb/c mice for 2, and 4 consecutive wks. Administration for 4 wks enhanced the number of total T cells, NK cells and MHC class II+ cells, and CD4-CD8+ T cells in flow cytometry analysis. To determine of antitumor activity of LABs preparation in vivo, F9 teratocarcinoma cells were inoculated on mice at 14th day. Body weight was decreased with increased survival rate in all groups with the cytoplasm of LABs. Our results showed that cytoplasmic fraction of LABs had direct antiproliferative effects on tumor cell lines in vitro, effects on immune cells in vivo, and antitumor effects on tumor-bearing mice with prolonged survival periods.

100 Deals associated with Y-400

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Indication	Highest Phase	Country/Location	Organization	Date
Wet age-related macular degeneration	Phase 2	CN	Shenzhen Kangzhe Weisheng Pharmaceutical Development Co., Ltd.	16 Aug 2023

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