Ksl-w(Ksl-w) - 在研适应症：牙龈炎_专利_临床

概要

基本信息

药物类型

合成多肽

别名-

靶点-

作用机制-

治疗领域

感染口颌疾病

在研适应症

牙龈炎

非在研适应症-

原研机构

United States Army Medical Research and Materiel Command

在研机构

United States Army Medical Research and Materiel Command

非在研机构-

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 Ksl-w 相关的临床试验

NCT02864901 / Completed临床2期IIT

A Double-Blind, Randomized, Placebo Controlled, Clinical Trial of an Antiplaque Chewing Gum (30 mg) - Phase 2 Proof of Concept in a Generally Healthy Patient Population

This study is a Phase 2 two-armed placebo-controlled, double-blind, randomized (1:1), multiple dose, single center study to evaluate the safety and proof of concept in a chewing gum formulation 3 times per day over 4 treatment days.

开始日期2016-10-01

申办/合作机构

U S Army Medical Research & Development Command

NCT01877421 / Completed临床1/2期IIT

A Double-Blind, Randomized, Controlled, Dose Escalation Clinical Trial of an Antiplaque Chewing Gum - Phase 1 Safety and Tolerability and Phase 2a Safety, Tolerability, and Proof of Concept in a Gingivitis Population

This study is to assess the safety and tolerability of single doses and multiple doses in reducing plaque and gingivitis when delivered in a chewing gum formulation.

开始日期2014-02-25

申办/合作机构

U S Army Medical Research & Development Command

100 项与 Ksl-w 相关的临床结果

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100 项与 Ksl-w 相关的转化医学

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100 项与 Ksl-w 相关的专利（医药）

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41

项与 Ksl-w 相关的文献（医药）

2024-12-01·Clinical and Experimental Dental Research

Combined Phase 1/2a Initial Clinical Safety Trials and Proof‐of‐Concept Assessment of a Novel Antimicrobial Peptide KSL‐W Anti‐Plaque Chewing Gum

Article

作者: Kirkwood, Brian J. ; Ryan, J. Brett ; Leung, Kai P.

ABSTRACTObjectivesThe effective control of dental plaque is crucial for oral health, given that pathogenic bacteria in plaque are the primary cause of dental caries. Current antimicrobial agents, although effective, disrupt the oral microbiome and lead to oral dysbiosis, hindering efforts to curb dental caries. Novel antimicrobial peptides offer a promising solution due to their selective bactericidal activity against cariogenic bacteria. This study explores the initial safety and efficacy of KSL‐W formulated into chewing gum through a Phase 1 and 2a clinical trial.MethodsThe combined trial, approved by the FDA, follows a double‐blind, randomized, placebo‐controlled design. Phase 1 assessed safety with single doses (2−100 mg), whereas Phase 2a explored both safety and proof of concept in reducing oral bacteria with multiple doses (4−75 mg). Besides adverse events (Phase 1), outcome measures included whole‐mouth plaque and gingival index scores and bleeding on probing (Phase 2a).ResultsKSL‐W demonstrated safety in both phases, with no severe adverse events. The proof‐of‐concept analysis revealed a decrease in plaque and gingival inflammation, particularly at doses ≥ 20 mg. The 30 mg dose appeared to yield optimal effects without any adverse reactions in subjects.ConclusionsResults from this study indicate that KSL‐W is safe for use in humans and provides initial evidence of its potential efficacy in reducing plaque and gingival inflammation. Further research is essential to determine optimal usage and ultimate safety, and to assess its potential in diverse populations.Trial RegistrationThe trial is registered with the FDA (Trial Registration Number: NCT01877421). The clinical trials were registered in the clinicaltrials.gov database under the title “Safety and Tolerability of Antiplaque Chewing Gum in a Gingivitis Population” and the identifier number is NCT01877421. The URL for accessing the study in clinicaltrials.gov is https://clinicaltrials.gov/study/NCT01877421?intr=Antiplaque%20chewing&rank=1.

2022-10-01·Drug Delivery and Translational Research3区 · 医学

Sustained-release ketamine-loaded lipid-particulate system: in vivo assessment in mice

3区 · 医学

Article

作者: Kumar, Vinod ; Cui, Cedric S ; Borges, Karin ; Xu, Weizhi ; Whittaker, Andrew K ; Smith, Maree T ; Maqbool, Faheem ; Woodruff, Trent M ; Han, Felicity Y ; Falconer, James R

Ketamine is used as an analgesic adjuvant in patients with chronic cancer-related pain. However, ketamine's short half-life requires frequent dose administration. Our aim was to develop a sustained release formulation of ketamine with high loading and to evaluate the in vivo pharmacokinetics and biodistribution in mice. Here, ketamine hydrochloride sustained-release lipid particles (KSL) were developed using the thin-film hydration method. The mean (± SD) encapsulation efficiency (EE) and drug loading (DL) of KSL were 65.6 (± 1.7)% and 72.4 (± 0.5)% respectively, and the mean (± SD) size of the lipid particles and the polydispersity index were 738 (± 137) nm and 0.44 (± 0.02) respectively. The release period of KSL in pH 7.4 medium was 100% complete within 8 h in vitro but a sustained-release profile was observed for more than 5 days after intravenous injection in mice. Importantly, the KSL formulation resulted in a 27-fold increase in terminal half-life, a threefold increase in systemic exposure (AUC_0-∞), and a threefold decrease in clearance compared with the corresponding pharmacokinetics for intravenous ketamine itself. Our findings demonstrate high encapsulation efficiency of ketamine in the sustained-release KSL formulation with prolonged release in mice after systemic dose administration despite 100% in vitro release within 8 h that requires future investigation.

2022-02-01·Food Research International1区 · 农林科学

Kefir modulates gut microbiota and reduces DMH-associated colorectal cancer via regulation of intestinal inflammation in adulthood offsprings programmed by neonatal overfeeding

1区 · 农林科学

Article

作者: Dutra Medeiros, Julliane ; Otavio do Amaral Corrêa, José ; Cristina Potente Dutra Luquetti, Sheila ; Barbosa Ferreira Machado, Alessandra ; Teodoro de Souza, Claudio ; Novaes Rocha, Vinícius ; Paula Boroni Moreira, Ana ; Guiomar de Almeida Brasiel, Poliana ; do Carmo Gouveia Peluzio, Maria

Obesity is associated with chronic inflammation, intestinal dysbiosis, and colorectal cancer risk. The anti-cancer effects of kefir are highlighted. Here, lactating Wistar rats were divided into: Normal litter (NL); Kefir normal litter (KNL); Small litter (SL); Kefir small litter (KSL). The NL and SL groups received 1 mL of water/day; KNL and KSL received kefir milk daily (10⁸ CFU/mL) during lactation. After weaning, the pups continued to receive the same treatments until 60 days. At 67 days old, colorectal carcinogenesis was induced through intraperitoneal injection of 1,2-dimethylhydrazine. At 240 days, visceral adipose tissue was higher in SL compared to NL, KNL, and KSL. Kefir intake was found to suppress the number of tumors in both KNL and KSL groups (-100% and -71.43%; p < 0.01, respectively). IL-1β, IL-6, TNF-α, and NO levels in the colon were higher in the NL and SL compared to the KNL and KSL. The gut microbiota in cecal samples of SL was enriched with Alloprevotella, Acinetobacter, and Bacteroides. In contrast, the cecal contents of KSL and KNL were higher Romboutsia. Thus, neonatal overfeeding leads to greater adiposity, inflammation and number of colon tumors in adulthood. Early-life nutrition based on kefir reverted these alterations.

100 项与 Ksl-w 相关的药物交易

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