A Randomized, Double-Blind Trial Comparing the Pharmacokinetics of CT-P16, a Candidate Bevacizumab Biosimilar, with its Reference Product in Healthy Adult Males.

BACKGROUND: CT-P16 is a candidate biosimilar of bevacizumab, a monoclonal antibody targeting vascular endothelial growth factor that is used in the treatment of a range of advanced solid cancers. OBJECTIVE: The objective of this study was to demonstrate the pharmacokinetic equivalence of CT-P16 and European Union (EU)-approved bevacizumab (EU-bevacizumab) and US-licensed bevacizumab (US-bevacizumab) reference products. METHODS: In this double-blind, parallel-group phase I trial (ClinicalTrials.gov identifier NCT03247673), healthy adult males were randomized (1:1:1) to receive a single dose of CT-P16 5 mg/kg, EU-bevacizumab 5 mg/kg, or US-bevacizumab 5 mg/kg. Primary study endpoints were area under the concentration-time curve (AUC) from time zero to infinity (AUC∞), AUC from time zero to the last quantifiable concentration (AUClast), and maximum serum concentration (Cmax). Pharmacokinetic equivalence was shown if the 90% confidence intervals (CIs) of the geometric mean (GM) ratios of the AUC∞, AUClast, and Cmax were within the predefined bioequivalence margin of 80-125%. Safety and immunogenicity were also evaluated. RESULTS: A total of 144 subjects were randomized: 47 to CT-P16, 49 to EU-bevacizumab, and 48 to US-bevacizumab. The 90% CIs for the GM ratios of AUC∞, AUClast, and Cmax for CT-P16/EU-bevacizumab, CT-P16/US-bevacizumab, and EU-bevacizumab/US-bevacizumab comparisons were all within the bioequivalence margin. Mean serum concentration-time profiles, secondary pharmacokinetic parameters, and safety and immunogenicity profiles were comparable across all three treatment groups. CONCLUSION: CT-P16 demonstrated pharmacokinetic equivalence to EU-bevacizumab and US-bevacizumab. Safety and immunogenicity profiles were similar for CT-P16, EU-bevacizumab, and US-bevacizumab. These data support the further clinical evaluation of CT-P16 as a bevacizumab biosimilar. CLINICAL TRIALS REGISTRATION: NCT03247673.

Mesoporous Three-Dimensional Graphene Networks for Highly Efficient Solar Desalination under 1 sun Illumination.

Solar desalination via thermal evaporation of seawater is one of the most promising technologies for addressing the serious problem of global water scarcity because it does not require additional supporting energy other than infinite solar energy for generating clean water. However, low efficiency and a large amount of heat loss are considered critical limitations of solar desalination technology. The combination of mesoporous three-dimensional graphene networks (3DGNs) with a high solar absorption property and water-transporting wood pieces with a thermal insulation property has exhibited greatly enhanced solar-to-vapor conversion efficiency. 3DGN deposited on a wood piece provides an outstanding value of solar-to-vapor conversion efficiency, about 91.8%, under 1 sun illumination and excellent desalination efficiency of 5 orders salinity decrement. The mass-producible 3DGN enriched with many mesopores efficiently releases the vapors from an enormous area of the surface by heat localization on the top surface of the wood piece. Because the efficient solar desalination device made by 3DGN on the wood piece is highly scalable and inexpensive, it could serve as one of the main sources for the worldwide supply of purified water achieved via earth-abundant materials without an extra supporting energy source.

Highly transparent poly(glycidyl methacrylate-co-acryloisobutyl POSS) for 100 µm-thick submicron patterns with an aspect ratio over 100.

This is the first report on the fabrication of defect-free submicron structures with more than 100 µm thickness and an aspect ratio over 100. Highly transparent poly(glycidyl methacrylate-co-acryloisobutyl POSS) (PGP) was synthesized via radical polymerization. The mechanical properties of the PGP submicron structure displayed a Young's modulus of 6.09 GPa and a hardness of 0.16 GPa, 4.2 and 8 times, respectively, than those of SU8 nanopatterns. These enhancements enable the utilization of ultrathick 2D-/3D-submicron structures as an ideal platform for microelectromechanical systems, big data storage systems, energy devices, etc.