NCT06216093

Phase I, First-In Human Study to Evaluate Safety and Tolerability of EuRSV in Healthy Adults Aged Between 19 Years and 80 Years

Phase I, Randomized, Observer-blind, Placebo-control, Parallel-group, first-in Human Study to Evaluate Safety and Tolerability of EuRSV in Healthy Adults Aged Between 19 Years and 80 Years

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: EuBiologics Co.,Ltd · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Phase 1 clinical trial to evaluate the safety of RSV-1 and RSV-2 vaccines in healthy adults aged 19 to 80 years who have voluntarily given written consent to participate in this study.

Conditions

• Respiratory Syncytial Virus Infections
• Respiratory Syncytial Virus (RSV)

Interventions

Type	Name	Description
BIOLOGICAL	EuRSV	Healthy adults received 0.5mL single intramuscular dose on Day 0 and Day 28.
OTHER	Placebo Comparator	Healthy adults received 0.5mL single intramuscular dose on Day 0 and Day 28.

Timeline

• Start date: 2024-05-08
• Primary completion: 2025-07-31
• Completion: 2025-09-30
• First posted: 2024-01-22
• Last updated: 2025-06-15

Locations

1 site across 1 country: South Korea