At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 40 enrolled
Drug / intervention
CA-008 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating CA-008 and Placebo for Hallux Valgus Deformity. Completed, enrolled 40 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHallux Valgus Deformity
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedOct 2017
Enrollment StartNov 2017
Primary CompletionMar 2018
Study CompletionApr 2018
TodayJul 2026
First PostedOct 12, 2017
Enrollment StartNov 2, 2017
Primary CompletionMar 20, 2018
Study CompletionApr 25, 2018
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.7 years ago
Interventions
CA-008drug
Local administration during surgery
Placebodrug
Local administration during surgery