A Study to Evaluate the Safety and Effectiveness of Different Doses of Chrysalin in Adults Who Have a Broken Wrist
Radius Fracture
About this trial
This is an interventional treatment trial for Radius Fracture focused on measuring Chrysalin, TP508, Fracture, Wrist, Healing
Eligibility Criteria
Inclusion Criteria: An unstable and/or displaced fracture of the distal radius Fracture classified as primary intra-articular or extra-articular Male, or non-pregnant, non-lactating female at least 18 years old. If female of childbearing potential, must have confirmed negative pregnancy test prior to administration of study product. Must agree to use a medically approved method of birth control for 6 months. Need ability to understand study requirements, provide written informed consent, and comply with study protocol Need ability to understand and provide written authorization for use and disclosure of health information per Health Insurance Portability and Accountability Act (HIPAA) Exclusion Criteria: History of distal radius fracture of the affected limb 2 years prior to study enrollment History of uncontrolled Type I or Type II diabetes mellitus History or clinical evidence of any active medical disease or condition which would make the subject, in the opinion of the investigator, unsuitable for the study, or could potentially confound the results of the study Concurrent use of other investigational (non-Food and Drug Administration [FDA]-approved) agent or device Participation in any other clinical study within 90 days prior to treatment with the study drug Female subjects who are pregnant or nursing
Sites / Locations
- OrthoLogic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
10 micrograms
30 micrograms
Placebo
3 micrograms
1 microgram