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ARMS-I (a Formulation of Cetylpyridinium Chloride -CPC) | Clinical Trials | Clareo Health

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

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

NCT03026205•University of Toledo Health Science Campus

View on ClinicalTrials.gov

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.

Detailed 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.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Men and women 18 to 45 years of age, inclusive
•Ability to understand the consent process and procedures
•Informed consent obtained and signed
•Comprehension of the protocol, which will be determined by the recruiter after explaining the procedures
•Subjects agree to be available for all study visits. Subjects will be asked if they have any travel plans, and whether staff could use alternate contact information that will be provided.
•General good health as determined by the Study Physician, without current medical illness or clinically significant abnormal physical examination findings that classify the subject as other than healthy
•Negative urine pregnancy test at screening and a negative urine pregnancy test on the day of initial pharmacokinetic sampling for all female subjects of child bearing potential
•Negative urine toxicity screen for marijuana, cocaine metabolites, amphetamines, opiates, PCP, barbiturates, benzodiazepines
•Negative breathalyzer for alcohol
•Body mass index (BMI) between 18 and 35 (inclusive) \[weight (kg)\]/ \[height (m)2\]
+5 more criteria

Exclusion Criteria

•Hypertension with confirmed systolic blood pressure \>140 mmHg or confirmed diastolic blood pressure \>90 mmHg, measured after 10 - 15 minutes of rest
•Morbid obesity (BMI\>35)
•Current diagnosis of pulmonary disease including asthma or COPD, which has required use of asthma medications within the past year
•History of or current diagnosis of diabetes
•Autoimmune disorder, such as systemic lupus erythematosus, Wegener's disease, or rheumatoid arthritis, among other conditions
•History of malignancy except low-grade skin cancer, (i.e., basal cell carcinoma which has been surgically cured)
•Chronic renal, hepatic, or pulmonary disease condition that could interfere with the absorption of the study drug (e.g., surgical resection of significant proportions of the stomach or bowel, gastric bypass, gastric banding, irritable bowel syndrome, inflammatory bowel disease)
•Blood donation within the previous 6 weeks
•History of cardiac rhythm abnormality
•History of prolonged QT interval
+21 more criteria

Locations (1)

ProMedica Health System

Toledo, Ohio, United States

Key Dates

Start Date

January 1, 2017

Primary Completion Date

January 1, 2017

Completion Date

January 1, 2017

Last Updated

April 17, 2019

Conditions

Viral Upper Respiratory Tract Infection

Interventions

ARMS-I

DRUG

To Evaluate the Clinical Efficacy and Safety of Recombinant Human Interferon ω Spray in Treatment of Viral Upper Respiratory Tract Infection in Children

NCT05859984

Viral Upper Respiratory Tract Infection

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 17, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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