8 results
To evaluate the safety and tolerability of ascending single and multiple oral doses of ADX71441 as compared to placebo in healthy volunteers.To evaluate the pharmacokinetics of orally administered single and multiple doses of ADX71441 and its…
- 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 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…
Primary: efficacy of belimumab for the treatment of IMN.Secondary: safety and tolerability, PK, PD, quality of life, benefit of earlier treatment initiation.
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…
* To evaluate the efficacy of belimumab in combination with standard of care in adult subjects with lupus nephritis Class III, IV, or V using the 2003 ISN/RPS criteria. * To assess the safety and tolerability of belimumab plus standard of care…
Primary: safety and tolerability of belimumab in a pediatric population (5-17 y) with SLE.Secondary: PK, efficacy, quality of life.
Primary:To evaluate the efficacy of belimumab and a single cycle of rituximab administered in a combination regimen to adult participants with SLE. Secondary:Other aspects of efficacy. Safety and tolerability. Questionnaires.