A Phase 2, Multicenter, Randomized, Double-Blind, Dose-Escalating/De-Escalating Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of a Single Dose of Sustained-Release Encapsulated Bupivacaine (SKY0402) in the Management of Post-Operative Pain in Subjects Undergoing Inguinal Hernia Repair

INTERVENTION: Product Name: Sustained‐Release Encapsulated Bupivacaine Product Code: SKY0402 Pharmaceutical Form: Suspension for injection INN or Proposed INN: Bupivacaine CAS Number: 2180‐92‐9 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 175‐350 Trade Name: Marcain Polyamp Steripack 0.5% Product Name: Marcain Polyamp Steripack 0.5% Pharmaceutical Form: Solution for injection INN or Proposed INN: Bupivacaine CAS Number: 2180‐92‐9 Concentration unit: % percent Concentration type: equal Concentration number: 0.5‐ CONDITION: Pain following inguinal hernia repair ; MedDRA version: 6.0 Level: LLT Classification code 10022020 PRIMARY OUTCOME: Main Objective: To determine the appropriate dose of SKY0402 for the management of post‐operative pain following inguinal hernia repair. Primary end point(s): Efficacy: Time to first use of supplemental pain medication (opioid or non‐opioid) post‐operatively for wound healing.; ; Safety: Vital signs, 12‐lead ECG, physical examination, routine laboratory tests, AEs and SAEs, wound healing evaluation. Secondary Objective: To evaluate the safety, efficacy, and pharmacokinetics of various doses of SKY0402 (starting at 175 mg and increasing/decreasing in an incremental fashion, with the dose not to exceed 350 mg) compared to a single 100 mg dose of unencapsulated bupivacaine. INCLUSION CRITERIA: 1. Males greater than or equal to 18 years of age 2. Scheduled to undergo a unilateral inguinal hernia repair under general anesthesia, using an open, tension free procedure (e.g. Lichenstein technique with or without mesh 3. ASA Physical Class 1 or 2 4. Able and willing to comply with all study visits and procedures 5. Capable of speaking and understanding the local language sufficiently to provide responses to pain assessment scales 6. Willing and capable of providing written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range