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

  • STATUS
    Recruiting
  • participants needed
    126
  • sponsor
    Astellas Pharma Inc
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Updated on 19 February 2024
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body mass index

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.

Details
Condition Healthy Volunteers
Age 20years - 85years
Treatment ASP3772 (subcutaneous), ASP3772 (intramuscular), PPSV23 (subcutaneous), PPSV23 (intramuscular)
Clinical Study IdentifierNCT04265911
SponsorAstellas Pharma Inc
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Group 1: Subject is a healthy male or female between 20 and 49 years of age inclusive, at informed consent
Group 2: Subject is a male or female between 65 and 85 years of age inclusive, at informed consent who is healthy or has chronic controlled, stable disease with no change in disease severity, medical therapy and no hospitalization history in last 12 weeks from informed consent as determined by medical history, physical examination, and laboratory data
Female subject of non-childbearing potential; male subject not able to father children or who is able to father children and willing to use a highly effective method of contraception
Subject agrees not to participate in another interventional study while participating in the present study
Subject has a body mass index (BMI) range of 17.6 to 26.4 kg/m^2 inclusive in Group 1 and 15.4 to 28.6 kg/m^2 inclusive in Group 2, and body weight at least 50 kg for male and 40 kg for female at screening

Exclusion Criteria

Subject has had previous vaccination with any licensed or investigational pneumococcal vaccine at any time
Subject has a history of microbiologically-proven invasive disease caused by Streptococcus pneumoniae
Subject has an immune disorder(s) (including autoimmune disease), clinical conditions requiring immunosuppressive drugs and/or a close relative who has congenital immunodeficiency
Group 1: Subject has any illness that requires medication or treatment
Group 2: Subject has any evidence of unstable or active clinically significant cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease, e.g., uncontrolled hypertension, uncontrolled diabetes, heart failure, uncontrolled chronic obstructive pulmonary disease, end-stage renal disease, malignancy which is active and requires treatment
Subject has any clinically significant history of allergic conditions including drug allergies, asthma or anaphylactic reactions, but excluding untreated asymptomatic seasonal allergies just before study vaccine administration
Subject has a positive serology test for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), hepatitis A virus antibodies (immunoglobulin M), hepatitis C virus antibodies (anti-HCV) or antigens/antibodies to human immunodeficiency virus (HIV) type 1 and/or type 2 at screening
Subject has/had febrile illness or symptomatic of viral, bacterial (including upper respiratory infection) or fungal (excluding skin infection) infection within 7 days prior to day 1
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