A Phase I/IIa, Randomized, Double-Blind, Placebo-Controlled, Single Dose and Single-Dose Challenge Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Intranasal EV25 in Healthy Volunteers and in Influenza Challenge Participants

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514832-26-00

Enrollment

122

Registered

2024-11-07

Start date

2024-11-12

Completion date

2025-05-13

Last updated

2024-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Virus Influenza

Brief summary

Part I: AEs, laboratory safety assessments,12-lead ECG findings, vital signs, physical examination findings, and intranasal administration site examination findings.

Interventions

DRUGPlacebo for EV25 nasal spray

DRUGintranasal use

DRUGWild-Type A Influenza Virus A/Belgium/4217/2015 (H3N2)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part I: AEs, laboratory safety assessments,12-lead ECG findings, vital signs, physical examination findings, and intranasal administration site examination findings.	—

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026