6 results
Primary:To determine the safety, tolerability, and pharmacokinetic (PK) profile of single ascending intravenous (iv) doses and of multiple ascending iv doses of FMX-8 in healthy subjectsSecondary:To evaluate the pharmacodynamics (PD) of FMX-8 in…
Part 1 1. Determine if accumulation of the fluorescent tracer bevacizumab-800CW can be detected for identification of pancreatic cancer tissue during surgery.2. Identify two doses of conjugate that provide the best visualization of tumor tissue…
Parts D and E: Primary Objectives:• To evaluate the safety and tolerability of VX-445 in TC with TEZ and IVA in subjects with cystic fibrosis (CF)• To evaluate the efficacy of VX-445 in TC with TEZ and IVA in subjects with CFSecondary Objectives• To…
PrimairyTo assess whether bevacizumab-800CW allows for intraoperative fluorescence imaging of perihilar cholangiocarcinoma and what dose provides the best visualization of tumor tissue by determining the tumor-to-background (TBR) ratio ex…
Part 11. Determine if accumulation of the fluorescent tracer bevacizumab-800CW can be detected for identification of soft tissue sarcoma during surgery.2. Identify two doses of bevacizumab-800CW that provide the best visualization of tumour tissue…
The primary objective of this study is to investigate the stability of the fixation in the bone of the use of the Legion prosthesis with cones in revision TKA, until 5 years postoperatively. The secondary objective of this study is to assess the…