BACKGROUND: RNA interference (RNAi) provides an attractive tool to modulate biological systems, and ultimately, to treat @entity1 diseases. We describe early results from a Phase Ib, first-in- @entity1 safety and tolerability study of an RNAi-based therapy, NUC B1000, among @entity1 with mild to moderate chronic @entity97 . METHODS: Three subjects received a single 5 mg DNA dose of NUC B1000 as part of a planned dose escalation study. RESULTS: All @entity1 reported @entity7551 , chills, @entity925 and fever approximately 4-7 h after dosing. All subjects were asymptomatic after a single antipyretic dose with no symptom recurrences. Measurements of interferon (IFN)-a and -y, interleukin (IL)-10, 12 18, 8 and 6, and @entity5 @entity39 factor-a performed before and after dosing revealed cytokine increases before study drug administration. After drug administration, @entity379 and @entity688 increased in two @entity1 ; @entity687 increased in one. Most increases returned to pretreatment levels within 1 week. Two @entity1 were subsequently successfully treated with @entity17705 indicating that NUC B1000 does not compromise subsequent antiviral therapy. CONCLUSIONS: Thus far, NUC B1000 appears safe and well-tolerated; safety and efficacy studies across a larger, more diverse @entity1 spectrum using increasing doses are needed to determine its appropriate role in the antiviral armamentarium.

RNA interference and its potential applications to chronic XXXX treatment: results of a Phase I safety and tolerability study.

@entity1 :: ('9606', 'Species') :: ['participants', 'human', 'patients', 'patient'] @entity97 :: ('10407', 'Species') :: ['HBV'] @entity39 :: ('MESH:D009336', 'Disease') :: ['necrosis'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumour'] @entity7551 :: ('MESH:D010612', 'Disease') :: ['pharyngitis'] @entity17705 :: ('MESH:C413685', 'Chemical') :: ['entecavir'] @entity688 :: ('3586', 'Gene') :: ['IL-10'] @entity379 :: ('3458', 'Gene') :: ['IFN-y'] @entity687 :: ('3576', 'Gene') :: ['IL-8'] @entity925 :: ('MESH:D063806', 'Disease') :: ['myalgia']
@entity97 :: (10407,Species) :: ['HBV']
