Dose-Escalation Safety and Pharmacokinetic Study of K305
Condition: Anesthesia
Intervention: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Intervention description: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Tetracaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine the pharmacokinetics/pharmacodynamics and safety of
      a nasal spray containing the anesthetic drug tetracaine in combination with oxymetazoline
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female between 18 and 65 years of age

          -  BMI between19 and 29 kg/m2

          -  Sufficiently healthy as determined by the investigator to receive the test medications
             and undergo the scheduled study procedure

          -  Can breathe through both nostrils

          -  Females of child-bearing potential must have a negative urine pregnancy test and must
             have been using adequate means of birth control for at least one month prior to study
             entry and during the study

          -  Screening BP ≤ 140/90

          -  Screening SpO2 ≥ 96

          -  Can understand and sign the informed consent document

          -  Can communicate with the investigator

          -  Can understand and comply with the requirements of the protocol.

        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