Bunionectomy

The study is designed to evaluate the safety, efficacy, and pharmacokinetics (PK) of two doses of AMT-143 in participants after unilateral bunionectomy.

This is a Phase 2 clinical trial of GRT7040, currently being developed for the treatment of moderate-to-severe acute pain. The primary purpose of this trial is to assess efficacy and safety of GRT7040 compared with placebo in adult participants with acute pain following bunionectomy. The trial will compare three different doses of GRT7040 given from Day 1 until Day 3 (eg, 48 h after the first investigational medicinal product \[IMP\] administration) of GRT7040 or placebo.

This is a Phase 2, randomized, double-blind, active-controlled, dose-escalation study evaluating the safety, pharmacokinetics, efficacy, and pharmacodynamics of ALX006, an extended-release bupivacaine formulation, administered as a single-dose sciatic nerve block in the popliteal fossa in adult subjects undergoing primary unilateral bunionectomy. Approximately 60 subjects will be enrolled across 3 sequential dose cohorts (100 mg, 150 mg, 200 mg ALX006), with each cohort comparing ALX006 against MARCAINE 0.25% (bupivacaine HCl 50 mg) as the active comparator at a 3:1 randomization ratio. Dose escalation between cohorts is governed by an Independent Data Monitoring Committee.