Calendario›OPK›LY2944876
LY2944876
A Study of LY2944876 in Healthy Japanese and Non-Japanese Participants
Ensayo de OPKO HEALTH, INC. en Voluntarios sanos.
- Fase
- Fase 1
- Estado
- Interrumpido
- Participantes
- 48
- Centros
- 1
- Fin del objetivo primario
- dic 2014
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, doble ciego. Comenzó en jul 2014.
Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «The termination criteria of the protocol was met during dose escalation.».
Qué mide
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to Be Related to Study Drug Administration (Pre-dose (PRD) through Study Completion (Up to Day 40)) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroLY2944876 is an investigative drug for the treatment of Type 2 Diabetes Mellitus. Part A of the study will assess the safety and tolerability of single doses of LY2944876 in Japanese participants. Participation is expected to last up to about 7 weeks, not including screening. Part B of the study will investigate the safety and tolerability of multiple doses of LY2944876 in non Japanese participants. Participation is expected to last up to about 8 weeks, not including screening. All doses will be administered as injections into the fatty layer just beneath the skin. Screening is required within 28 days prior to the start of the study. All participants will attend a post study safety assessment approximately 6 weeks after their final dose.
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Todos los de OPK, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT02188303), actualizada en may 2021.