scholarly journals Safety and Tolerability of Essential Oil fromCinnamomum zeylanicumBlume Leaves with Action on Oral Candidosis and Its Effect on the Physical Properties of the Acrylic Resin

2014 ◽  
Vol 2014 ◽  
pp. 1-10 ◽  
Author(s):  
Julyana de Araújo Oliveira ◽  
Ingrid Carla Guedes da Silva ◽  
Leonardo Antunes Trindade ◽  
Edeltrudes Oliveira Lima ◽  
Hugo Lemes Carlo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Essential Oil ◽  
Phase I ◽  
Artificial Saliva ◽  
Clinical Signs ◽  
Acrylic Resin ◽  
Phase I Clinical Trial ◽  
Cinnamomum Zeylanicum ◽  
Oral Candidosis ◽  
Dental Prostheses

The anti-Candidaactivity of essential oil fromCinnamomum zeylanicumBlume, as well as its effect on the roughness and hardness of the acrylic resin used in dental prostheses, was assessed. The safety and tolerability of the test product were assessed through a phase I clinical trial involving users of removable dentures. Minimum inhibitory concentration (MIC) and minimum fungicidal concentrations (MFC) were determined against twelveCandidastrains. Acrylic resin specimens were exposed to artificial saliva (GI),C. zeylanicum(GII), and nystatin (GIII) for 15 days. Data were submitted to ANOVA and Tukey posttest (α=5%). For the phase I clinical trial, 15 healthy patients used solution ofC. zeylanicumat MIC (15 days, 3 times a day) and were submitted to clinical and mycological examinations.C. zeylanicumshowed anti-Candidaactivity, with MIC = 625.0 µg/mL being equivalent to MFC. Nystatin caused greater increase in roughness and decreased the hardness of the material (P<0.0001), with no significant differences between GI and GII. As regards the clinical trial, no adverse clinical signs were observed after intervention. The substance tested had a satisfactory level of safety and tolerability, supporting new advances involving the clinical use of essential oil fromC. zeylanicum.

scholarly journals Two Live Attenuated Vaccines against Recent Low–and Highly Pathogenic H7N9 Influenza Viruses Are Safe and Immunogenic in Ferrets

Vaccines ◽  
2018 ◽  
Vol 6 (4) ◽  
pp. 74 ◽  
Author(s):  
Larisa Rudenko ◽  
Irina Kiseleva ◽  
Elena Krutikova ◽  
Ekaterina Stepanova ◽  
Irina Isakova-Sivak ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase I ◽  
Reverse Genetics ◽  
Vaccine Candidate ◽  
Clinical Signs ◽  
Influenza Viruses ◽  
Phase I Clinical Trial ◽  
World Health ◽  
Histological Data ◽  
Health Organization

Influenza H7N9 virus is a potentially pandemic subtype to which most people are immunologically naïve. To be better prepared for the potential occurrence of an H7N9 pandemic, in 2017 the World Health Organization recommended developing candidate vaccine viruses from two new H7N9 viruses, A/Guangdong/17SF003/2016 (A/GD) and A/Hong Kong/125/2017 (A/HK). This report describes the development of live attenuated influenza vaccine (LAIV) candidates against A/GD and A/HK viruses and study of their safety and immunogenicity in the ferret model in order to choose the most promising one for a phase I clinical trial. The A/HK-based vaccine candidate (A/17/HK) was developed by classical reassortment in eggs. The A/GD-based vaccine candidate (A/17/GD) was generated by reverse genetics. Ferrets were vaccinated with two doses of LAIV or phosphate-buffered saline. Both H7N9 LAIVs tested were safe for ferrets, as shown by absence of clinical signs, and by virological and histological data; they were immunogenic after a single vaccination. These results provide a compelling argument for further testing of these vaccines in volunteers. Since the A/HK virus represents the cluster that has caused the majority of human cases, and because the A/HK-based LAIV candidate was developed by classical reassortment, this is the preferred candidate for a phase I clinical trial.

scholarly journals Preclinical Safety Evaluation of Intravenously Administered SAL200 Containing the Recombinant Phage Endolysin SAL-1 as a Pharmaceutical Ingredient

2014 ◽  
Vol 58 (4) ◽  
pp. 2084-2088 ◽  
Author(s):  
Soo Youn Jun ◽  
Gi Mo Jung ◽  
Seong Jun Yoon ◽  
Yun-Jaie Choi ◽  
Woo Suk Koh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase I ◽  
Evaluation Studies ◽  
Clinical Signs ◽  
Safety Evaluation ◽  
Phase I Clinical Trial ◽  
Repeated Dose ◽  
Daily Injection ◽  
Toxicity Studies ◽  
Repeated Dose Toxicity

ABSTRACTPhage endolysins have received increasing attention as potent antibacterial agents. However, although safety evaluation is a prerequisite for the drug development process, a good laboratory practice (GLP)-compliant safety evaluation has not been reported for phage endolysins. A safety evaluation of intravenously administered SAL200 (containing phage endolysin SAL-1) was conducted according to GLP standards. No animals died in any of the safety evaluation studies. In general toxicity studies, intravenously administered SAL200 showed no sign of toxicity in rodent single- and repeated-dose toxicity studies. In the dog repeated-dose toxicity test, there were no abnormal findings, with the exception of transient abnormal clinical signs that were observed in some dogs when daily injection of SAL200 was continued for more than 1 week. In safety pharmacology studies, there were also no signs of toxicity in the central nervous and respiratory system function tests. In the cardiovascular function test, there were no abnormal findings in all tested dogs after the first and second administrations, but transient abnormalities were observed after the third and fourth administrations (2 or 3 weeks after the initial administration). All abnormal findings observed in these safety evaluation studies were slight to mild, were apparent only transiently after injection, and resolved quickly. The safety evaluation results for SAL200 support the implementation of an exploratory phase I clinical trial and underscore the potential of SAL200 as a new drug. We have designed an appropriate phase I clinical trial based on the results of this study.

scholarly journals Evaluation of pharmacodynamic properties and safety of Cinnamomum zeylanicum (Ceylon cinnamon) in healthy adults: a phase I clinical trial

2017 ◽  
Vol 17 (1) ◽  
Author(s):  
Priyanga Ranasinghe ◽  
Ranil Jayawardena ◽  
Shehani Pigera ◽  
Wasundara Sevwandi Wathurapatha ◽  
Hasitha Dhananjaya Weeratunga ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase I ◽  
Healthy Adults ◽  
Phase I Clinical Trial ◽  
Cinnamomum Zeylanicum ◽  
Ceylon Cinnamon
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