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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

2020-02-16 17:40:49 | BioPortfolio

Summary

The purpose of this study is to evaluate the safety and tolerability of 3 different dose levels of ASP3772 administered subcutaneously or intramuscularly to Japanese healthy adults 20 to 49 years of age.

This study will also evaluate the safety and tolerability of 3 different dose levels of ASP3772 administered subcutaneously or intramuscularly, in comparison to the active comparator 23-valent pneumococcal polysaccharide vaccine (PPSV23) in Japanese elderly subjects 65 to 85 years of age.

Study Design

Conditions

Healthy Volunteers

Intervention

ASP3772 (subcutaneous), ASP3772 (intramuscular), PPSV23 (subcutaneous), PPSV23 (intramuscular)

Status

Not yet recruiting

Source

Astellas Pharma Inc

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-02-16T17:40:49-0500

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A Single Ascending Dose Study in Adults (Stage 1) and Single Ascending Dose-Finding Study (Stage 2) in Elderly Subjects With ASP3772, A Pneumococcal Vaccine

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PubMed Articles [857 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

The uptake of substances via the SUBCUTANEOUS TISSUE.

Presence of air or gas in the subcutaneous tissues of the body.

The measurement of subcutaneous fat located directly beneath the skin by grasping a fold of skin and subcutaneous fat between the thumb and forefinger and pulling it away from the underlying muscle tissue. The thickness of the double layer of skin and subcutaneous tissue is then read with a caliper. The five most frequently measured sites are the upper arm, below the scapula, above the hip bone, the abdomen, and the thigh. Its application is the determination of relative fatness, of changes in physical conditioning programs, and of the percentage of body fat in desirable body weight. (From McArdle, et al., Exercise Physiology, 2d ed, p496-8)

Uptake of substances via muscle tissue.

An uncommon complication of INTRAMUSCULAR INJECTION leading to variable degrees of necrosis of skin and underlying tissue.

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A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe, its toxins or one ...


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