A Single-dose Open-Label Study to Assess the Safety and Preliminary Efficacy of PRF 110 in Open Herniorrhaphy Surgery

• Male subjects between 18-70 years of age who are scheduled to undergo open one sided herniorrhaphy surgery;
• Subjects have a BMI of less than 30 kg/m2;
• Subjects are in good physical health (other than the need for the surgical procedure) as judged by physical and laboratory examinations and have a negative urine based screen for drugs of abuse;
• Subjects must agree to refrain from ingesting any analgesic medication for at least 2 days (or 5 half-lives of the analgesic drug) prior to surgery; refrain from alcohol and excessive caffeine intake on the day of surgery and during 72 hours after surgery;
• Subject must be capable of reading, comprehending, and signing the informed consent form;

Exclusion Criteria:

• Subjects with a history of melena or any significant hepatic, renal, endocrine, cardiac, neurological, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorders;
• Subjects with a history of any type of cancer within 5 years of surgery;
• Subjects with any history of alcohol or substance abuse;
• Subjects that have a history of uncontrolled hypertension;
• Subjects with a known hypersensitivity to any local anesthetic drug;
• Subjects with a hemoglobin concentration of less than 10.0 g/dL;
• Subjects with any clinically significant abnormal lab result (as judged by the Principal Investigator);
• Subjects with atrial fibrillation/flutter, an inserted pacemaker, or complete left bundle branch block (LBBB) on ECG; or myocardial infarction within 6 months prior to surgery;
• Subjects with a clinically significant abnormal ECG at screening;
• Subjects with any condition or history judged by the Investigator to place the subject at increased risk;
• Subjects judged by the Investigator to be unable or unwilling to comply with the requirements of the protocol;
• Subjects who have used an investigational drug within 30 days prior to entering the study;
• Subjects who have donated blood within 3 months prior to the start of the study;
• Subjects who are members of the study site staff directly involved with the study or a relative of the Sponsor or other personnel involved with the study;