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ISIS 113715

Examination of Dermatologic Effects From Subcutaneous Injections of ISIS 113715

Ensayo de IONIS PHARMACEUTICALS INC en Diabetes tipo 2.

Más ensayos de: Diabetes tipo 2.

Fase

Fase 1

Estado

Completado

Participantes

10

previstos

Centros

1

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en ago 2006.

Qué mide

Compare the dermatologic responses to 200 mg/1.0 mL and 200 mg/2.0 mL ISIS 113715 administered subcutaneously into separate abdominal sites, with both injections given on the same day. (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registro10 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.

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Todos los de IONS, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00365781), actualizada en oct 2007.