CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
CCH (collagenase clostridium histolyticum)biological
Likely dose
CCH (collagenase clostridium histolyticum) 3.36 mgfrom 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.

Search/NCT03675685
NCT03675685Phase 1Completed
CompareCT.gov

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

Endo Pharmaceuticals·interventional·Posted Sep 18, 2018·Updated Oct 6, 2020

In Brief

A Phase 1 clinical trial evaluating CCH (collagenase clostridium histolyticum) for Edematous Fibrosclerotic Panniculopathy. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEdematous Fibrosclerotic Panniculopathy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedSep 18, 2018
Enrollment StartSep 18, 2018
Primary CompletionNov 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 7.8 years ago

Interventions

CCH (collagenase clostridium histolyticum)biological

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.