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A Phase 1/Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of a Single Intraoperative Administration of CA-008 in Subjects Undergoing Unilateral Transpositional First Metatarsal Osteotomy for the Correction of Hallux Valgus Deformity

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Trial Profile

A Phase 1/Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of a Single Intraoperative Administration of CA-008 in Subjects Undergoing Unilateral Transpositional First Metatarsal Osteotomy for the Correction of Hallux Valgus Deformity

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 06 Jul 2021

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At a glance

  • Drugs Vocacapsaicin (Primary)
  • Indications Postoperative pain
  • Focus Adverse reactions; First in man; Pharmacokinetics
  • Sponsors Concentric Analgesics
  • Most Recent Events

    • 11 Sep 2018 According to a Concentric Analgesics media release, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to CA-008 for post-surgical pain, decision was supported by data from this study.
    • 16 Jul 2018 Status changed from active, no longer recruiting to completed.
    • 14 May 2018 According to a Concentric Analgesics media release, the company anticipates presenting complete data, including pharmacokinetics and full 28-day follow-up results, from the trial later in 2018.
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