6 results
The primary objective is to investigate the effects of intravenous administration of C1INH in human volunteers on cytokine release (TNFa) during endotoxemia. The secondary objective is to determine the effect of administration of C1 INH on…
A previous study of from our laboratory showed that administration of the drug C1-INH (100E/kg) significantly reduced the concentration of circulating pro-inflammatory cytokines, such as IL-6, in healthy male volunteers during human experimental…
- Primary objective: The effect of C1-INH prior to induction of a systemic inflammation by endotoxin (E. coli lipopolysaccharide), on the leukocyte phenotype, activation and mobilization. - Secondary objectives: - Determine the effect of C1-…
The primary efficacy objectives of this two-cohort study are:o To demonstrate that ZX008 is superior to placebo as adjunctive therapy in the treatment of symptoms of Dravet syndrome in children and young adults based on change in the frequency of…
The primary objective of Part 1 is the primary objective of the entire study.Part 1The primary objective of Part 1 is:* To evaluate the effect of ZX008 0.8 mg/kg/day versus placebo as adjunctive therapy for the treatment of uncontrolled seizures in…
Objectives for Part 1: Primary (Efficacy): To demonstrate that the efficacy of fenfluramine (ZX008) 0.8 mg/kg/day is superior to placebo as an adjunctive therapy for pediatric and adult subjects with CDD Secondary (Safety): To characterize the…