NCT06344975

A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine STR-V003 in Healthy Adults

A Phase 1/2, Randomized, Placebo-Controlled, Double-Blind, Dose-Finding, First-in-Human Study of Respiratory Syncytial Virus (RSV) mRNA Vaccine STR-V003 in Healthy Adults

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Starna Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo-controlled, single ascending dose escalation and two-dose study in healthy adults. This study will be conducted in healthy men and women ≥18 years old to assess the safety, tolerability and immunogenicity of STR-V003. This trial consists of two parts: Part A and Part B.

Conditions

• Respiratory Syncytial Virus Infections

Interventions

Type	Name	Description
BIOLOGICAL	STR-V003/Placebo	IM

Timeline

• Start date: 2024-05-01
• Primary completion: 2024-12-01
• Completion: 2025-05-01
• First posted: 2024-04-03
• Last updated: 2024-04-03

Regulatory

• FDA-regulated drug study