drugset / Trial / NCT03675685

Safety and Pharmacokinetics of a Single Dose of CCH (3.36 mg) in Subjects With EFP

NCT03675685

Phase 1 Completed 12 enrolled Endo USA Inc., a Keenova Therapeutics Company
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

EvaluationDrugModalityDoseRoute
Subject Collagenase Clostridium Histolyticum Protein / enzyme biologic 3.36 mg Subcutaneous