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

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

Recruiting
Phase of Trial: Phase I

Latest Information Update: 21 Nov 2017

At a glance

  • Drugs CA-008 (Primary)
  • Indications Postoperative pain
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Concentric Analgesics
  • Most Recent Events

    • 15 Nov 2017 Planned primary completion date changed from 1 Dec 2018 to 1 Jan 2018.
    • 02 Nov 2017 Status changed from not yet recruiting to recruiting according to a Concentric Analgesics media release.
    • 02 Nov 2017 According to a Concentric Analgesics media release, results from this trial are expected in the first quarter of 2018.
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