NCT06681402

Phase I Single-blind Clinical Trial to Evaluate the Safety and Local Immune Activation of a Toll-like Receptor 5 Agonist (FLAMOD) Administered by Aerosol

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a single-blind, randomized, placebo-controlled, dose-escalation phase I monocentric trial assessing a single administration of FLAMOD by aerosol in healthy subjects. The recruitment is performed by the Clinical Investigation Center of Tours. This trial is divided in two stages: * the "start-up phase" consisting of a dose escalation to ensure the safety of FLAMOD while allowing sufficient information on the molecule activity to be accumulated * the dose-finding phase estimating several dose-activity models and then selecting the one that best fits the data to then propose the dose for the next cohort of participants.

Conditions

• Pneumonia

Interventions

Type	Name	Description
DRUG	FLAMOD	FLAMOD (GMP-grade flagellin) inhalation
DRUG	Placebo	Placebo inhalation

Timeline

• Start date: 2025-04-14
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2024-11-08
• Last updated: 2026-04-16

Locations

1 site across 1 country: France