Study of Wafermine™ for Post-bunionectomy or Abdominoplasty Pain

• Status: Completed
• Trial end date: 2018-07-17
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the safety and effectiveness of Wafermine™ for post-bunionectomy or post-abdominoplasty pain over a 24 hours period. For subjects undergoing bunionectomy, 2 out of 3 subjects will receive Wafermine™ and 1 out of 3 subjects will receive placebo. For subjects undergoing abdominoplasty, 3 out of 4 subjects will receive Wafermine™ and 1 out of 4 subjects will receive placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: iX Biopharma Ltd.

Criteria

Inclusion Criteria:

• Scheduled for a bunionectomy or mini abdominoplasty with no additional planned procedures.

• Good general health without clinically significant renal, hepatic, cardiac or respiratory disease, as determined by the Investigator.

Exclusion Criteria:

• For those undergoing bunionectomy, other painful conditions involving the surgical foot.

• Positive lab values for Hepatitis B or C or HIV