NCT03307837

A Phase 1 Study of Intraoperative Administration of CA-008 for the Correction of Hallux Valgus Deformity

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 Correction of Hallux Valgus Deformity

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Concentric Analgesics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, randomized, double-blind, placebo-controlled, single ascending dose, sequential-group Phase 1 study. The study will be conducted utilizing a cohort design, with sequential groups of 8 subjects. Within each dose cohort, 6 subjects will be randomized to active, and 2 will be randomized to placebo.

Detailed description

This is a single-center, randomized, double-blind, placebo-controlled, single ascending dose, sequential-group Phase 1 study. The study will be conducted utilizing a cohort design, with sequential groups of 8 subjects. Within each dose cohort, 6 subjects will be randomized to active, and 2 will be randomized to placebo. Placebo patients from each cohort were pooled for analysis. The initial cohort will receive the lowest planned dose of CA-008, and sequential cohorts will receive escalating doses of CA-008 in a fixed volume of administration. There will be at least a 6-day period between cohorts, in order to ensure a minimum of 3 days to review safety data from the last subject in a cohort and to allow the meeting of the Data Monitoring Committee (DMC) to review the safety data from the entire cohort prior to a making decision for dose escalation. Dose escalation rules will be protocol defined. Subjects will be undergoing unilateral transpositional first metatarsal osteotomy for the correction of hallux valgus deformity (bunionectomy). In accordance with standard of care, subjects will receive regional anesthesia (MAYO block) with 0.5% bupivacaine. Prior to wound closure, 10 mL of study drug will be injected into the soft tissues and periosteum of the surgical site. After the surgery, subjects will be monitored for 48 hours at the trial site. Safety and efficacy evaluations will be performed as described herein. Subjects will be required to meet certain pre-specified criteria prior to discharge.

Conditions

• Hallux Valgus Deformity

Interventions

Type	Name	Description
DRUG	CA-008	Local administration during surgery
DRUG	Placebo	Local administration during surgery

Timeline

• Start date: 2017-11-02
• Primary completion: 2018-03-20
• Completion: 2018-04-25
• First posted: 2017-10-12
• Last updated: 2021-06-30
• Results posted: 2021-06-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study