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REGN728

Ascending Dose Study of the Safety and Tolerability of REGN728 in Healthy Volunteers

Ensayo de REGENERON PHARMACEUTICALS, INC. en Voluntarios sanos.

Fase

Fase 1

Estado

Completado

Participantes

48

previstos

Centros

2

Fin del objetivo primario

mar 2012

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en ago 2010.

Qué mide

The primary endpoint in the study is the percentage of subjects with treatment emergent adverse events, reported from the administration of study drug on day 1 to the completion of the study on day 106. (del registro, en inglés) (106 dias)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis study will test the safety and tolerability (how the body reacts to the drug) of REGN728 compared with placebo (an inactive substance that contains no medicine) in healthy subjects. The study drug and placebo will be administered by subcutaneous injection (under the skin) at the clinic visit. There will be 14 clinic visits, which will include 4 overnight stays. Subjects will be monitored by the study staff for side effects and the body's response to the study drug. Vital signs (blood pressure, temperature, breathing and heart rate) will be checked, blood and urine samples will be collected at some or all visits.

Más ensayos de REGN

Todos los de REGN, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01197391), actualizada en nov 2012.