Single Ascending Dose of ASP3772 Study in Japanese Healthy Male and Female Adults, and Single Ascending Dose Study of ASP3772 in Comparison With PPSV23 in Japanese Elderly Male and Female Subjects

Author(s):  
2013 ◽  
Vol 35 (8) ◽  
pp. 1150-1161.e3 ◽  
Author(s):  
Wenhui Zhang ◽  
Ronald Smulders ◽  
Anura Abeyratne ◽  
Albert Dietz ◽  
Walter Krauwinkel ◽  
...  

2021 ◽  
Vol 7 (3) ◽  
pp. 249-255
Author(s):  
C.S Janaki ◽  
Mukta Sachdev ◽  
Ritambhara

Most available therapeutics to address alopecia are based on singular targets and mechanism of action based on the assumption of sub-classification to reflect morphological or etiological sub-classes such as hereditary vs acquired factors, anti-inflammatory vs. non-inflammatory factors or scarring vs. non-scarring factors. Impact of oral consumption of Diabliss Hair Water, a multi-component herbal water supplement (HWS) on hair fall reduction, hair growth, hair density, hair thickness was investigated in a single arm, exploratory, pilot open label clinical study among healthy male and female subjects of age group between 35-50 years, with hair fall and hair thinning concerns. The study was conducted under dermatological control and included hair fall by comb test, hair pull test, hair thinning measurement using photo numerical scale (modified Norwood and Ludwig scale) and assessment for hair quality along with the phototrichogram assessment using Trichoscan® with Cutiscope. The Diabliss HWS was efficacious in improving hair growth rate and density as per TrichoScan® assessment, improvement in hair thickness as per Caslite-Nova software. The Diabliss HWS was also efficacious in improving the hair tensile strength (break force by Chatillon Force gauge), reducing hair fall and improving the hair quality. By the end of the study the Diabliss HWS was found to show an improvement in the entire study population in all of the assessments parameters. Dermatologist assessment parameters of hair texture and hair shine also showed improvements in the entire study population. The Diabliss HWS was found to be efficacious in providing hair fall control and hair growth benefits as per the dermatological and instrumental evaluations using TrichoScan®. The product was well tolerated with no product related AE or SAE with regular consumption for 06 months.


Author(s):  
Nor Aziyatul Izni Mohd Rosli ◽  
Mohd Azizi Abdul Rahman ◽  
Malarvili Balakrishnan ◽  
Takashi Komeda ◽  
Saiful Amri Mazlan ◽  
...  

This study is aimed to explore the Heart Rate Variability (HRV) response during short-term exercise by stair stepper and to compare the finding between young healthy male and female subjects. The responses were statistically analyzed by applying independent-samples t-test statistical method. The calculation of Coefficient of Variation (CoV (%)) and the slope of the linear regression is used to assess the steadiness of the HRV. Furthermore, the results also demonstrated that female subjects had greater significant p-value of RMSSD feature and significance p-value in a LF feature is greater in male. Thus, the ongoing results demonstrated that males have the sympathetic drive and females have predominant parasympathetic drive using short-term exercise by stepper. Thus, the experiment results indicate the suitability of developing rehabilitation devices in the field of Autonomic Nervous System (ANS), research, control system and rehabilitation enginering, which may help to isolate males and females.


1977 ◽  
Author(s):  
M.S. Sirridge ◽  
R. Shannon

Because of the increased interest in the role of Antithrombin III as a physiologic coagulation inhibitor and because of some previous problems we encountered in sequential measurement of this protein, the present study was designed to answer 3 questions: 1) Which of four methods (2 functional activity methods and 2 immunologic methods) is the most practical, accurate and reproducible? 2) Do normal subjects have relatively constant levels when tested sequentially by these methods? 3) What is the range of Antithrombin III levels in young healthy male and female subjects? A serum pool was tested by each of the 3 serum methods at least 20 different times throughout the study. The von Kaulla functional activity method gave the lowest standard deviation and coefficient of variation. In the group of 29 subjects this method proved to be the most practical and also gave very low coefficients of variation for individual subjects when they were tested from 11 to 16 times (range .023-.054). The other methods did not give such low coefficients of variation for individual subjects. The range of levels was 77 to 110% on 344 samples tested by the von Kaulla method With a mean of 92.8% and a standard deviation of 6.4%. The standard deviations for the pool and for individual subjects were greater but quite satisfactory for all methods.


Digestion ◽  
2004 ◽  
Vol 69 (2) ◽  
pp. 123-130 ◽  
Author(s):  
P. Enck ◽  
H. Franz ◽  
F. Azpiroz ◽  
X. Fernandez-Fraga ◽  
H. Hinninghofen ◽  
...  

Author(s):  
Kim Henriksen ◽  
Karen Broekhuizen ◽  
Wadim de Boon ◽  
Morten Karsdal ◽  
Asger Bihlet ◽  
...  

There is a need for anti-diabetic agents successfully targeting insulin sensitivity and treating obesity control at the same time. The aim of this first-in-human study was 1) to evaluate safety and tolerability; 2) to evaluate pharmacokinetics and 3) to assess indications of receptor engagement of single ascending doses of KBP-042, a Dual Amylin and Calcitonin Receptor Agonists (DACRA) that has shown promising preclinical data, with superior activity in terms of typical amylin-induced responses including reduction of food intake, weight loss and gluco-regulatory capacities. A randomised double-blind placebo-controlled single ascending dose study was performed with six dose levels of KBP-042 (5, 7.5, 10, 20, 20 evening and 40µg) in healthy male adults. KBP-042 or placebo was administered as a single dose after an overnight fast, followed by a standardized lunch after four hours. KBP-042 was associated with dose-dependent complaints of nausea and vomiting, with a lack of tolerability at doses of 20µg and above. Doses of 5 to 40 μg KBP-042 were behaved according to a linear pharmacokinetic profile. Indications of target receptor engagement were observed at the level of glucose control and lowering of bone resorption, compared to placebo. The results of this study showed that doses up to 40 μg were safe, although tolerability was not present at the highest doses. The study confirmed target receptor engagement at the studied doses.


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