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RTA 1701 capsules

Safety and PK/PD of RTA 1701 in Healthy Adults

Ensayo de BIOGEN INC. en Sano.

Fase

Fase 1

Estado

Completado

Participantes

90

previstos

Centros

1

Fin del objetivo primario

jun 2019

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en jun 2018.

Qué mide

Incidencia de acontecimientos adversos surgidos del tratamiento (3 semanas)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis first-in-human, Phase 1, single-center study will evaluate single ascending doses (SAD) and multiple ascending doses (MAD) of RTA 1701 conducted in 2 parts. Part 1 (SAD) of this study will be conducted in approximately 56 healthy participants in up to 7 groups. Each group will consist of up to 8 participants who will be randomized in a 3:1 ratio to receive a single dose of RTA 1701 or placebo, respectively. Safety, tolerability, and available pharmacokinetics in each group will be assessed by the Safety Monitoring Committee prior to dose escalation. Part 2 (MAD) of this study will be conducted in approximately 30 healthy participants in up to 3 groups and will commence after safety data for the highest dose in the SAD phase has been evaluated. Each group will consist of up to 10 participants who will be randomized in a 4:1 ratio to receive 14 daily doses of RTA 1701 or placebo, respectively. Safety, tolerability, and available pharmacokinetics will be assessed in each dosing group prior to dose escalation

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Ficha completa en ClinicalTrials.gov (NCT03579030), actualizada en may 2025.