drugset / Trial / NCT00365781

Examination of Dermatologic Effects From Subcutaneous Injections of ISIS 113715

NCT00365781 ↗

Phase 1 Completed 10 enrolled Ionis Pharmaceuticals, Inc.
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2006-08
Primary completion
—
Completion
2006-09

Drugs

EvaluationDrugModalityDoseRoute
Subject ISIS 113715 Antisense oligonucleotide 200 mg Subcutaneous