NCT04265911

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

ASP3772 Phase 1 Study: Single Ascending Dose Study in Japanese Healthy Male and Female Adults, and PPSV23-controlled, Randomized, Single Ascending Dose Study in Japanese Elderly Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Affinivax, Inc. · Industry
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
BIOLOGICAL	ASP3772 (subcutaneous)	Subcutaneous injection
BIOLOGICAL	ASP3772 (intramuscular)	Intramuscular injection
BIOLOGICAL	PPSV23 (subcutaneous)	Subcutaneous injection
BIOLOGICAL	PPSV23 (intramuscular)	Intramuscular injection

Timeline

• Start date: 2020-02-19
• Primary completion: 2020-11-07
• Completion: 2020-11-07
• First posted: 2020-02-12
• Last updated: 2022-05-02

Locations

1 site across 1 country: Japan

Regulatory

• FDA-regulated drug study