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
Phase of Trial: Phase I
Latest Information Update: 11 Sep 2018
At a glance
- Drugs CA-008 (Primary)
- Indications Postoperative pain
- Focus Adverse reactions; First in man; Pharmacokinetics
- Sponsors Concentric Analgesics
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History