Dose-Escalation Safety and Pharmacokinetic Study of K305

Exclusion Criteria

• •A clinically relevant history or presence of respiratory, thyroid, gastrointestinal, renal, hepatic, hematological, lymphatic, cardiovascular, psychiatric, neurologic, musculoskeletal, genitourinary, infective, inflammatory, immunological, dermatological, or connective tissue disease or disorder or a clinically relevant history or presence of narrow angle glaucoma and in men benign prostatic hypertrophy, Hashimoto"s Thyroiditis, lymphocytic thyroiditis, or uncontrolled diabetes
• •Clinically significant abnormalities in laboratory values
• •Clinically relevant sinus/nasal surgical history
• •Current condition, such as nasal congestion or sinus infection, that may influence responses to study medication
• •History of recurrent nose bleeds
• •History of pseudocholinesterase deficiency or previous prolonged paralysis with succinylcholine or "difficulty waking up from general anesthesia"
• •Allergic to or intolerant of tetracaine, benzocaine, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreens)
• •Allergic to or intolerant of oxymetazoline or preservatives found in these solutions
• •History of alcoholism and/or drug abuse
• •Have taken a monamine oxidase inhibitor, or vasopressor drug within the past 3 weeks
• •Have received or taken local anesthetics within 72 hours of the first or second treatment visits
• •Are nursing, pregnant, suspected of being pregnant, or trying to become pregnant (Females will be required to take a urine pregnancy test at each study visit to rule out pregnancy)
• •Have used any investigational drug and/or participated in any clinical trial within 30 days of baseline