ARMS-I (a Formulation of Cetylpyridinium Chloride -CPC) — ARMS-I  

Viral Upper Respiratory Tract Infection Clinical Trial

Official title: Evaluation of the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of Orally Administered ARMS-I Administered in Healthy Adults, Aged 18-45 Years

Status Withdrawn

Clinical Trial Summary

This is a single center study to evaluate the pharmacokinetics of ARMS-I a formulation that incorporates cetylpyridinium chloride (CPC), administered once as a single dose of three sprays orally, followed by multiple dosing (3x daily oral sprays) over days 3-6 and then a repeat pharmacokinetic study during the final oral dose administered as the first dose on day 7 to ascertain CPC accumulation.

Clinical Trial Description

ARMS Pharmaceuticals LLC intends to apply for approval of ARMS-I as a prescription drug for the prevention of influenza, rhinovirus and RSV (collectively, "vURTI's). The company plans on confirming the limited systemic bioavailability, through conducting a study to characterize the pharmacokinetics of ARMS-I administered orally in healthy adults. The primary objective of the study is to determine the pharmacokinetics of ARMS-I following oral administration to healthy subjects. Specifically, investigators will assess whether there is measurable systemic exposure and if so, to determine the plasma and pharyngeal fluid pharmacokinetic characteristics of ARMS-I after single and multiple oral dosing. The secondary objective will be to evaluate the safety and tolerability of ARMS-I. ;

Related Conditions & MeSH terms

• Common Cold
• Respiratory Tract Infections
• Viral Upper Respiratory Tract Infection

• NCT number: NCT03026205
• Study type: Interventional
• Source: University of Toledo Health Science Campus
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 2017
• Completion date: January 2017