6 results
To evaluate the inter- and intra-subject variability in pharmacokinetics (PK) and pharmacodynamics (PD) of study drug following a two-period repeated single dose of 2 mg delivered by subcutaneous (SC) injection in healthy volunteers.
To examine the effect of rituximab on endothelial activation, endothelial dysfunction, IMT and AGE accumulation in active RA.
Primary objectives:The primary objectives of this trial are:• To show PK similarity of BI 695500 to MabThera® and Rituxan® and of Rituxan® to MabThera® (three-way PK similarity).• To establish statistical equivalence of efficacy of BI 695500 and…
The primary objective:To demonstrate that CT-P10 is similar to Rituxan in terms of pharmacokinetics as determined by AUCtau and CmaxSS at Cycle 4 and maximum serum concentration at steady state The secondary objective:Efficacy: the primary endpoints…
PRINCIPAL OBJECTIVE To evaluate whether sequential therapy with tacrolimus for 9 months (6 months of full therapy and 3 months of tapering doses) followed by a dose of RTX leads to a greater increase in the proportion of primary MN patients with…
To measure in vivo biodistribution of 89Zirconium labeled GSK2849330 and characterize its dose receptor occupancy relationship in subjects with advanced HER3 positive solid malignancies.