Trials / Completed
CompletedNCT03675685
Safety and Pharmacokinetics of a Single Dose of CCH (3.36 mg) in Subjects With EFP
A Phase 1, Open-Label Study to Assess the Safety and Pharmacokinetics of a Single Dose of CCH (3.36 mg) in Subjects With Edematous Fibrosclerotic Panniculopathy
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Endo Pharmaceuticals · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CCH (collagenase clostridium histolyticum) | A single dose of 3.36 mg of CCH will be administered as subcutaneous injections (CCH 0.84 mg) per quadrant concurrently in 4 quadrants. A quadrant is defined as one of the following: left buttock, right buttock, left posterolateral thigh, or right posterolateral thigh. |
Timeline
- Start date
- 2018-09-18
- Primary completion
- 2018-11-01
- Completion
- 2018-11-01
- First posted
- 2018-09-18
- Last updated
- 2020-10-06
- Results posted
- 2020-10-06
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03675685. Inclusion in this directory is not an endorsement.