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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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.

2024-06-01·Regenerative Therapy

Unveiling the superior function of RADA in bone regeneration compared to KSL as two critical cores within self-assembling peptide nanofibers: Insights from in vitro and in vivo studies

Article

作者: Rasoulian, Bita ; Tavakol, Shima ; Rezayat, Seyed Mahdi ; Houshdar Tehrani, Mohammad Hassan ; Chegeni, Solmaz ; Hoveizi, Elham ; Sheikholislam, Zahra

IntroductionSelf-assembling peptide nanofibers have emerged as promising biomaterials in the realm of bone tissue engineering due to their biocompatibility, biodegradability, and ability to mimic the native extracellular matrix. This study delved into the comparative efficacy of two distinct self-assembling peptide nanofibers, RADA-BMHP1 and KSL-BMHP1, both incorporating the biological motif of BMHP1, but differing in their core peptide sequences.MethodsCell viability and osteogenic differentiation in rat mesenchymal stem cells (rMSCs), and bone regeneration in rat were compared.ResultsIn vitro assays revealed that KSL-BMHP1 promoted enhanced cell viability, and nitric oxide production than RADA-BMHP1, an effect potentially attributable to its lower hydrophobicity and higher net charge at physiological pH. Conversely, RADA-BMHP1 induced superior osteogenic differentiation, evidenced by upregulation of key osteogenic genes, increased alkaline phosphatase activity (ALP), and enhanced matrix mineralization which may be attributed to its higher protein-binding potential and grand hydropathy, facilitating interactions between the peptide nanofibers and proteins involved in osteogenesis. In vivo experiments utilizing a rat bone defect model demonstrated that both peptide nanofibers improved bone regeneration at the genes level and ALP activity, with RADA-BMHP1 exhibiting a more pronounced increase in bone formation compared to KSL-BMHP1. Histological evaluation using H&E, Masson's trichrome and Wright-Giemsa staining confirmed the biocompatibility of both nanofibers.ConclusionThese findings underscore the pivotal role of the core structure of self-assembling peptide nanofibers, beyond their biological motif, in the fate of tissue regeneration. Further research is warranted to optimize the physicochemical properties and functionalization of these nanofibers to enhance their efficacy in bone regeneration applications.

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.

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