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SPR994

Phase 1 Study of Safety, Tolerability and Pharmacokinetics of SPR994

Ensayo de Spero Therapeutics, Inc. en Voluntarios sanos.

Fase

Fase 1

Estado

Completado

Participantes

124

previstos

Centros

1

Fin del objetivo primario

ago 2018

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en oct 2017.

Qué mide

Safety measures: adverse events (SAD: 1 to 7 days or 1 to 13 (food effect cohort); MAD 1 to 20 days) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a double-blind, placebo-controlled, ascending dose, multi-cohort trial. The study will be conducted in 2 parts: a single ascending dose (SAD) part, followed by a multiple ascending dose (MAD) part. In SAD, all subjects will receive 1 dose of SPR994 (100, 300, 600 or 900 mg) or placebo, except for subjects enrolled in food effect cohorts in which subjects will receive one dose following a 10 hour fast and a second dose in the fed state following a minimum 5 days washout period. There is a single, optional, open-label control cohort that may enroll, in which all 8 subjects will receive Orapenem® (tebipenem pivoxil fine granules). In MAD, subjects will receive multiple doses of SPR994 (300 or 600 mg) or placebo for 14 consecutive days at either BID or TID dosing. In both parts, cohorts will be exposed to increasing doses of SPR994 with various extended release formulations.

Más ensayos de SPRO

Todos los de SPRO, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT03395249), actualizada en ago 2018.