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RTA 901 Capsules

A Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of RTA 901 in Healthy Adults

Ensayo de BIOGEN INC. en Voluntarios sanos.

Fase

Fase 1

Estado

Completado

Participantes

78

previstos

Centros

1

Fin del objetivo primario

jul 2017

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en ene 2017.

Qué mide

Safety and tolerability will be assessed by monitoring adverse events, physical examinations, clinical laboratory tests, 12-lead ECGs, and vital signs (del registro, en inglés) (14 dias)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis study will assess the safety, tolerability, and pharmacokinetic profile of RTA 901 following escalating single and multiple oral doses of RTA 901 in healthy adult subjects. This first-in-human, Phase 1, single-center study consists of single ascending doses (SAD) and multiple ascending doses (MAD) conducted in 2 parts. Part 1 (SAD) of this study will be conducted in approximately 56 healthy subjects in up to 7 groups. Each group will consist of up to 8 subjects who will be randomized in a 3:1 ratio to receive a single dose of RTA 901 or placebo, respectively. Safety, tolerability, and available pharmacokinetics through Day 4 will be assessed in each group prior to dose escalation. Part 2 (MAD) of this study will be conducted in approximately 30 healthy subjects in up to 3 groups. Each group will consist of up to 10 subjects who will be randomized in a 4:1 ratio to receive 14 daily doses of RTA 901 or placebo, respectively. Safety, tolerability, and available pharmacokinetics through Day 17 will be assessed in each dosing group prior to dose escalation.

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Ficha completa en ClinicalTrials.gov (NCT02666963), actualizada en may 2025.