drugset / Trial / NCT03675685
Safety and Pharmacokinetics of a Single Dose of CCH (3.36 mg) in Subjects With EFP
NaSingle-groupOpen-labelTreatment
Summary
This study will evaluate the safety and Pharmacokinetics (PK) of a single 3.36-mg dose of Collagenase Clostridium Histolyticum (CCH) in 4 quadrants concurrently, in subjects with Edematous fibrosclerotic panniculopathy (EFP). This study will provide insight to the PK profile and safety of concurrent subcutaneous injections of CCH 0.84 mg/quadrant into 4 quadrants.
Timeline
- Start
- 2018-09-18
- Primary completion
- 2018-11-01
- Completion
- 2018-11-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Collagenase Clostridium Histolyticum | Protein / enzyme biologic | 3.36 mg | Subcutaneous |