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NCT03675685 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics of a Single Dose of CCH (3.36 mg) in Subjects With EFP
A Phase 1 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT03675685: Completed Phase 1 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
NCT03675685 is a Phase 1 study that has completed, run by Endo USA Inc., a Keenova Therapeutics Company. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03675685, a Phase 1 study, has completed, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study 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.
Primary Outcome
Determine if there is systemic exposure following a subcutaneous single dose of Collagenase clostridium histolyticum (CCH) (3.36 mg) as 12 injections per quadrant in 4 quadrants concurrently (0.84 mg per quadrant) in adult women with Edematous Fibrosclerotic Panniculopathy (EFP). There were no quantifiable levels of plasma AUX-I or AUX-II observed at any collection time point following subcutaneous injection of EN3835. As a result, no pharmacokinetic (PK) parameters were calculated.
Interventions
- BIOLOGICAL CCH (collagenase clostridium histolyticum)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2018-09-18 |
| Est. Completion | 2018-11-01 |
| Phase | Phase 1 |
What the finished NCT03675685 record still lists
NCT03675685 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which CCH (collagenase clostridium histolyticum) is the first listed.
NCT03675685 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03675685 about?
NCT03675685 is a clinical study titled "Safety and Pharmacokinetics of a Single Dose of CCH (3.36 mg) in Subjects With EFP". 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 concurren...
What is the current status of trial NCT03675685?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2018-09-18. Estimated completion is 2018-11-01.
What interventions are being tested in trial NCT03675685?
The interventions under investigation include: CCH (collagenase clostridium histolyticum) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03675685?
This trial is sponsored by Endo USA Inc., a Keenova Therapeutics Company, which has 61 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03675685's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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