Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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. 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03675685
The ClinicalTrials.gov registry entry for NCT03675685 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endo USA Inc., a Keenova Therapeutics Company, which has 61 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CCH (collagenase clostridium histolyticum) is the first listed.
NCT03675685 reports 0 study locations.
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
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.