NCT02313155

Phase 1/2 Study of TAK-850 Subcutaneous Injection in Healthy Adults

A Randomized Double Blind Parallel-Group Comparative Phase 1/2 Study to Evaluate the Safety and Immunogenicity of a Single Subcutaneous Injection of TAK-850 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 20 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and immunogenicity of a single subcutaneous injection of TAK-850 as compared to intramuscular injection of TAK-850 in healthy Japanese adults

Detailed description

The drug being tested in this study is called TAK-850. This drug is being tested to evaluate the safety and immunogenicity of a single subcutaneous injection as compared to a single, intramuscular injection. A total of 110 healthy participants (55 per group) will take part in this study. Each participant will be randomly (like flipping a coin) assigned to receive one of the following : * A single injection of TAK-850, subcutaneously , or * A single injection of TAK-850, intramuscularly. Participants will make up to 3 visits to the study site. Total duration of this study is 22 days.

Conditions

• Influenza Infection

Interventions

Type	Name	Description
DRUG	Subcutaneous injection of TAK-850	TAK-850 0.5 mL, Subcutaneous injection
DRUG	Intramuscular injection of TAK-850	TAK-850 0.5 mL, Intramuscular injection

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2014-12-09
• Last updated: 2016-02-17
• Results posted: 2016-02-17