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NCT00365781 · ClinicalTrials.gov registry record · Phase 1
Examination of Dermatologic Effects From Subcutaneous Injections of ISIS 113715
A Phase 1 study, sponsored by Ionis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT00365781 is a Phase 1 study that has completed, run by Ionis Pharmaceuticals. The registered enrollment target is 10 participants.
The verdict
NCT00365781, a Phase 1 study, has completed, sponsored by Ionis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
10 healthy volunteers will be enrolled to each receive two subcutaneous injections of ISIS 113715 in the abdomen on Study Day 1. Each subject will receive their two injections within a 5-minute period. On Study Days 2 and 8, each subject's injection sites will be assessed for dermatologic effects. The Isis Project Physician(s) will observe the injection sites on Study Day 2 and may also observe on Study Day 8. Routine clinical chemistry, hematology, and urinalysis tests will be performed on Study Day 1 and Day 8. Subjects will be contacted by telephone on Study Day 30 to monitor for the occurrence of new serious adverse events (SAEs). Thereafter, the subjects will be discharged from the study.
Interventions
- DRUG ISIS 113715
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2006-08 |
| Est. Completion | 2006-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00365781
The ClinicalTrials.gov registry entry for NCT00365781 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ionis Pharmaceuticals, which has 76 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ISIS 113715 is the first listed.
NCT00365781 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00365781 about?
NCT00365781 is a clinical study titled "Examination of Dermatologic Effects From Subcutaneous Injections of ISIS 113715". 10 healthy volunteers will be enrolled to each receive two subcutaneous injections of ISIS 113715 in the abdomen on Study Day 1. Each subject will receive their two injections within a 5-minute period. On Study Days 2 and 8, each subject's injection sites will be assessed for dermatologic effects. T...
What is the current status of trial NCT00365781?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2006-08. Estimated completion is 2006-09.
What interventions are being tested in trial NCT00365781?
The interventions under investigation include: ISIS 113715 (DRUG).
Who is sponsoring clinical trial NCT00365781?
This trial is sponsored by Ionis Pharmaceuticals, which has 76 total clinical trials registered on ClinicalTrials.gov.
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