A Study of an Experimental Nasal Spray in Subjects With Early Signs of the Common Cold

This is an investigation in healthy subjects with early signs of common cold. Subjects will be randomly assigned in a 1:1 ratio to receive either Polymeric Nasal Spray or a matching placebo nasal spray.

Subjects will be screened for eligibility and randomized to treatment at the Screening/ Randomization Visit (Day 1). Subjects will apply the first dose of the nasal spray at this visit under supervision. The other applications will take place at home on Day 1. On Days 2 through 7, subjects will use their assigned nasal spray as 2 sprays per nostril, 4 times per day.

One Follow up Visit will be conducted within 3 days of the last application of nasal spray.

Enrollment will continue until 200 subjects have completed the investigation (100 per treatment group). The subject and the investigative staff will be blinded to the assigned nasal spray.

Efficacy will be measured, and recorded in the subject's diary, and safety will be assessed by reported AEs and ADEs.

Inclusion criteria

• Have early signs of a common cold: If female of child-bearing potential, have a negative pregnancy test at Screening.
• Have signed and dated the informed consent document, indicating that they have been informed of all pertinent aspects of the investigation
• Are willing and able to comply with scheduled visits, treatment plan, and other investigation procedures

Exclusion criteria

• Have had common cold or flu-like symptoms outside the protocol-specified parameters.
• Are current smokers as defined by the protocol.
• Have any medical history or condition or use any drug or device that (per protocol or in the opinion of the investigator) might compromise subject safety, participation in the trial, action of the investigational device, or results of the investigation..
• Are related to anyone involved with the conduct of the investigation.