Study Evaluating the Safety, Efficacy and Pharmacokinetics of CA-008

• Status: Completed
• Trial end date: 2020-10-26
• Target enrollment: 0
• Participant gender: All

Summary

In the pilot Part A of this study, multiple doses of CA-008 will be evaluated for safety, tolerability and PK. Doses will then be selected for the expanded, main part of the study where CA-008 will be compared to placebo. Patients will have serial assessments of safety, PK, and drug effect.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Concentric Analgesics

Criteria

Inclusion Criteria:

• Scheduled elective Total Knee Arthroplasty (TKA) under spinal anesthesia

• Aged 18-80 years old

• ASA physical class 1, 2, or 3

• BMI
• Generally healthy

Exclusion Criteria:

• Concurrent condition requiring analgesic treatment during study period

• Opioid tolerant

• Known allergy to capsaicin or other study medication

• Use of prohibited medications