Calendario›CTNM›PIPE-307

PIPE-307

Phase I Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of of PIPE-307 and Food Effect in Healthy Volunteers

Ensayo de Contineum Therapeutics, Inc. en Esclerosis multiple.

Más ensayos de: Esclerosis múltiple.

Fase

Fase 1

Estado

Completado

Participantes

70

previstos

Centros

1

Fin del objetivo primario

sep 2021

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en feb 2021.

Qué mide

Safety: Treatment-Emergent Adverse Events (TEAE) (From baseline to 7 days post dosing for SAD cohorts and 21 days post dosing for MAD cohorts) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a randomized, double-blind study of PIPE-307 or placebo in normal healthy subjects. The study will be conducted in three parts: Part 1 will be a Single Ascending Dose (SAD) study enrolling approximately 48 subjects for a total duration of 6 weeks. Part 2 will be a Multiple Ascending Dose (MAD) study enrolling approximately 24 subjects for a total duration of 7 weeks, and part 3 will be a selected SAD cohort in a fed state to evaluate the effect of food on the bioavailability of PIPE-307, enrolling approximately 8 subjects from a selected SAD cohort for a duration of 6 weeks.

Más ensayos de CTNM

Todos los de CTNM, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04725175), actualizada en nov 2021.