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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

NCT04265911 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2022-05-02

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

BIOLOGICAL

ASP3772 (subcutaneous)

Subcutaneous injection

BIOLOGICAL

ASP3772 (intramuscular)

Intramuscular injection

BIOLOGICAL

PPSV23 (subcutaneous)

Subcutaneous injection

BIOLOGICAL

PPSV23 (intramuscular)

Intramuscular injection

Sponsors & Collaborators

  • Affinivax, Inc.

    lead INDUSTRY

Principal Investigators

  • Central Contact · Astellas Pharma Inc

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-19
Primary Completion
2020-11-07
Completion
2020-11-07
FDA Drug
Yes

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04265911 on ClinicalTrials.gov