4 results
The study objectives are:- to characterize the biotransformation pathways, the routes and rates of excretion, and total recovery of the 14C-labeled research medication and its radiolabeled metabolites- to characterize the pharmacokinetics (PK) of…
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…
• To evaluate whether 7-day treatment with oral QLT091001 can improve visual function in subjects with LCA or RP caused by RPE65 or LRAT gene mutations.• To evaluate duration of visual function improvement (if observed) in subjects with LCA or RP…
We will assess the safety of adalimumab-800CW through the evaluation of both vital signs after tracer administration and possible (severe) adverse events (SAE/AE*s). Importantly, we will determine the feasibility of molecular fluorescence imaging…