Calendario›BIIB›RTA 408 Lotion 0.5%
RTA 408 Lotion 0.5%
RTA 408 Lotion in Healthy Volunteers
Ensayo de BIOGEN INC. en Voluntarios sanos.
- Fase
- Fase 1
- Estado
- Completado
- Participantes
- 109
- Centros
- 1
- Fin del objetivo primario
- abr 2014
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, doble ciego. Comenzó en dic 2013.
Qué mide
Skin changes or redness following topical application of RTA 408 lotion or lotion vehicle (del registro, en inglés) (14 dias)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis study is a first-in-human study of a topical dermal lotion formulation of RTA 408, a novel small molecule which suppresses oxidative stress and inflammation. In this study, the safety, local pharmacodynamics (PD), and systemic pharmacokinetics (PK) of RTA 408 will be evaluated following topical application of RTA 408 Lotion to healthy volunteers. This study will be conducted in three parts. In Part A of the study, healthy volunteers will have RTA 408 Lotion Vehicle and RTA 408 Lotion (0.5%, 1%, and 3%) applied to a small skin surface area (four individual 4-cm2 sites; 16 cm2 total area) twice daily for 14 days to assess the local skin tolerability, local PD, and systemic PK of these treatments. Part B will be conducted after completion of Part A and will assess the safety, tolerability, local PD, and systemic PK of RTA 408 Lotion applied topically twice daily for 14 days to a larger skin surface area (\~100 cm2). Part C will be conducted after completion of Part B and will assess the safety, tolerability, local PD, and systemic PK of RTA 408 Lotion applied topically twice daily for 28 days to a larger skin surface area (\~500 cm2). The maximum tolerated drug concentration in Part A will be used in Part B and Part C. Approximately 32 healthy adult volunteers will be enrolled in this study with 12 volunteers in Part A and 10 volunteers each, in Parts B and C.
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| Natalizumab | no aplica | En marcha, sin reclutar | oct 2026 (prevista) |
Todos los de BIIB, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT02029716), actualizada en may 2025.