NCT06857890

Safety, Tolerability, and Pharmacokinetic Profile of Grammidin With Anesthetic, a Metered Dose Topical Spray in Healthy Volunteers

An Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of the Drug Grammidin With Anesthetic, a Metered Dose Topical Spray Following Single Administration in Healthy Volunteers

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Valenta Pharm JSC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the safety, tolerability, and pharmacokinetic profile of the Grammidin with anesthetic, a metered dose topical spray, compared to Grammidin with anesthetic neo, lozenges following single administration in healthy volunteers.

Conditions

• Pharyngitis

Interventions

Type	Name	Description
DRUG	Grammidin with anesthetic neo	Grammidin with anesthetic neo, lozenges, 1 lozenge to be taken once under fed conditions.
DRUG	Grammidin with anesthetic, a metered dose topical spray	Grammidin with anesthetic, a metered dose topical spray, 4 sprays to be taken once under fed conditions

Timeline

• Start date: 2024-12-09
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-03-05
• Last updated: 2025-07-10

Locations

1 site across 1 country: Russia