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"Lee, Yongyoon"
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A Randomized, Double‐Blind, 2‐Treatment, 2‐Period, Crossover Phase 1 Study to Compare the Pharmacokinetics, Safety and Tolerability of 60 IU/Kg of Abcertin and Cerezyme in Healthy Volunteers Following a Single Intravenous Administration
2025
Background Imiglucerase (Cerezyme; Sanofi, Paris, France), an analogue of β‐glucocerebrosidase produced by recombinant DNA technology, has been a safe and effective treatment for Gaucher disease (GD) for over 25 years. A new imiglucerase, Abcertin (Seongnam‐si, Gyeonggi‐do, Republic of Korea) has shown a similar safety and efficacy profile in previous clinical studies. This study compared the pharmacokinetics, immunogenicity, safety, and tolerability to EU‐sourced Cerezyme following a single 60 IU/kg dose. Methods This phase 1, single‐center, randomized, double‐blind, two‐way crossover study enrolled 36 healthy volunteers aged 18–45 years. Participants were randomly assigned to receive either Abcertin or Cerezyme in a predetermined sequence. Results Abcertin reached peak plasma concentrations at a median tmax of 61 min (range: 40–121 min). The mean Cmax, AUC0–last, and AUC0–inf were 115.4 mU/mL, 12,190 min·mU/mL, and 12,210 min mU/mL, respectively, indicating bioequivalence to Cerezyme. The mean t½, CL, and Vz were 6.88 min, 376.7 mL/min, and 3.62 L, respectively, and were comparable between the two treatments. One participant in the Cerezyme group developed anti‐drug antibodies, which were non‐neutralizing A total of 24 subjects experienced treatment‐emergent adverse event (TEAE). The most common TEAE was headache (3 in the Abcertin group and 5 in the Cerezyme group), followed by general disorders and administration site condition (3 in Abcertin group and 5 in Cerezyme group). Two participants in the Cerezyme sequence experienced severe TEAEs: one had a urinary tract infection, and the other developed urticaria, which leading to study withdrawal. Conclusion Abcertin demonstrated pharmacokinetic equivalence to Cerezyme, with a comparable safety, immunogenicity, and tolerability profile. These findings support its potential as an affordable biosimilar for GD treatment. This study evaluates the pharmacokinetic equivalence, immunogenicity, and safety profiles of Abcertin and Cerezyme in healthy volunteers. It demonstrated the pharmacokinetic bioequivalence of Abcertin to Cerezyme, highlighted favorable safety and tolerability profiles with no clinically significant adverse events for Abcertin, and confirmed its low immunogenic potential.
Journal Article
Acetic Acid Assisted Crystallization Strategy for High Efficiency and Long‐Term Stable Perovskite Solar Cell
2020
Improving the quality of perovskite poly‐crystalline film is essential for the performance of associated solar cells approaching their theoretical limit efficiency. Pinholes, unwanted defects, and nonperovskite phase can be easily generated during film formation, hampering device performance and stability. Here, a simple method is introduced to prepare perovskite film with excellent optoelectronic property by using acetic acid (Ac) as an antisolvent to control perovskite crystallization. Results from a variety of characterizations suggest that the small amount of Ac not only reduces the perovskite film roughness and residual PbI2 but also generates a passivation effect from the electron‐rich carbonyl group (CO) in Ac. The best devices produce a PCE of 22.0% for Cs0.05FA0.80MA0.15Pb(I0.85Br0.15)3 and 23.0% for Cs0.05FA0.90MA0.05Pb(I0.95Br0.05)3 on 0.159 cm2 with negligible hysteresis. This further improves device stability producing a cell that maintained 96% of its initial efficiency after 2400 h storage in ambient environment (with controlled relative humidity (RH) <30%) without any encapsulation. Acetic acid (Ac) is used as an antisolvent for preparing perovskite films with excellent optoelectronic properties. Ac is found to not only reduce perovskite film roughness and residual PbI2 but also generate a passivation effect from the electron‐rich carbonyl group. The best 0.159 cm2 devices produce efficiencies of 22.0% for Cs0.05FA0.80MA0.15Pb(I0.85Br0.15)3 and 23.0% for Cs0.05FA0.90MA0.05Pb(I0.95Br0.05)3.
Journal Article