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20 results on '"Bae, Yunju"'

1. Efficacy and Safety of Candidate Biosimilar CT-P43 Versus Originator Ustekinumab in Moderate to Severe Plaque Psoriasis: 28-Week Results of a Randomised, Active-Controlled, Double-Blind, Phase III Study

Author

Papp, Kim A., Lebwohl, Mark G., Thaçi, Diamant, Jaworski, Janusz, Kwiek, Bartlomiej, Trefler, Jakub, Dudek, Anna, Szepietowski, Jacek C., Reznichenko, Nataliya, Narbutt, Joanna, Baran, Wojciech, Kolinek, Joanna, Daniluk, Stefan, Bartnicka-Maslowska, Katarzyna, Reich, Adam, Andrashko, Yuriy, Kim, Sunghyun, Bae, Yunju, Jeon, Dabee, Jung, Jinsun, Lee, Hyunseung, Pyo, Tina, and Ko, Woori

Published
2024
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2. Subcutaneous Infliximab (CT-P13 SC) as Maintenance Therapy for Inflammatory Bowel Disease: Two Randomized Phase 3 Trials (LIBERTY)

Author

Hanauer, Stephen B., Sands, Bruce E., Schreiber, Stefan, Danese, Silvio, Kłopocka, Maria, Kierkuś, Jarosław, Kulynych, Roman, Gonciarz, Maciej, Sołtysiak, Artur, Smoliński, Patryk, Srećković, Slobodan, Valuyskikh, Ekaterina, Lahat, Adi, Horyński, Marek, Gasbarrini, Antonio, Osipenko, Marina, Borzan, Vladimir, Kowalski, Maciej, Saenko, Daria, Sardinov, Ruslan, Lee, Sang Joon, Kim, Sunghyun, Bae, Yunju, Lee, Sunhee, Lee, Seulgi, Lee, Joon Ho, Yang, Siyoung, Lee, Jimin, Lee, Juhyun, Kim, Jong Min, Park, Gahee, Sandborn, William J., and Colombel, Jean-Frederic

Published
2024
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3. A randomized, double-blind, single-dose, phase 1 study comparing the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of denosumab biosimilar CT‑P41 and reference denosumab in healthy males

Author

Kim, Anhye, primary, Hong, Jang Hee, additional, Shin, Wonsuk, additional, Yoo, Hyounggyoon, additional, Jung, Jin-Gyu, additional, Reginster, Jean-Yves, additional, Kim, SungHyun, additional, Bae, YunJu, additional, Suh, JeeHye, additional, Kim, Sera, additional, Lee, EunKyung, additional, and Silverman, Stuart, additional

Published
2024
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4. Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 administered by auto-injector or pre-filled syringe: a randomized, open‑label, single-dose phase I study

Author

Yu, Kyung-Sang, Ryu, Hyunwook, Shin, Dongseong, Park, MinKyu, Hwang, JunGi, Moon, Seol Ju, Kim, Min-Gul, Keystone, Edward, Smolen, Josef S, Kim, SungHyun, Bae, YunJu, Jeon, DaBee, Jang, JiYoung, Yang, GoEun, Bae, JiHun, Lee, JaeYong, and Burmester, Gerd R

Abstract

ABSTRACTBackgroundThis study compared the pharmacokinetics (PK), immunogenicity, and safety of candidate tocilizumab biosimilar, CT-P47, administered via auto-injector (CT-P47 AI) or pre-filled syringe (CT-P47 PFS), in healthy Asian adults.Research design and methodsIn this phase I, multicenter, open-label study, participants were randomized 1:1 to receive a single 162 mg/0.9 mL dose of CT-P47 via AI or PFS. Primary endpoints were area under the concentration – time curve from time zero to infinity (AUC0–inf) and maximum serum concentration (Cmax). PK equivalence was determined if 90% confidence intervals (CIs) for the ratios of geometric least-squares means (gLSMs) were within the predefined 80–125% equivalence margin. Secondary PK parameters, immunogenicity, and safety outcomes were also assessed.ResultsOf 314 participants randomized (155 CT-P47 AI; 159 CT-P47 PFS), 310 received the study drug (153 CT-P47 AI; 157 CT-P47 PFS). Primary and secondary PK results, immunogenicity and safety were similar between groups. Ninety percent CIs for the ratio of gLSMs were within the predefined equivalence margin for AUC0–inf(85.87–102.94) and Cmax(82.98–98.16).ConclusionsPK equivalence between CT-P47 AI and CT-P47 PFS was demonstrated in healthy Asian adults, with comparable immunogenicity and safety between the two devices.Trial registrationClinicalTrials.gov: NCT05617183.

Published
2024
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5. Efficacy and Safety of Candidate Biosimilar CT-P43 Versus Originator Ustekinumab in Moderate to Severe Plaque Psoriasis: 28-Week Results of a Randomised, Active-Controlled, Double-Blind, Phase III Study

Author

Papp, Kim A., primary, Lebwohl, Mark G., additional, Thaçi, Diamant, additional, Jaworski, Janusz, additional, Kwiek, Bartlomiej, additional, Trefler, Jakub, additional, Dudek, Anna, additional, Szepietowski, Jacek C., additional, Reznichenko, Nataliya, additional, Narbutt, Joanna, additional, Baran, Wojciech, additional, Kolinek, Joanna, additional, Daniluk, Stefan, additional, Bartnicka-Maslowska, Katarzyna, additional, Reich, Adam, additional, Andrashko, Yuriy, additional, Kim, Sunghyun, additional, Bae, Yunju, additional, Jeon, Dabee, additional, Jung, Jinsun, additional, Lee, Hyunseung, additional, Pyo, Tina, additional, and Ko, Woori, additional

Published
2023
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6. Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 versus reference tocilizumab: a randomized, double-blind, single-dose phase I study

Author

Yu, Kyung-Sang, primary, Kim, Byungwook, additional, Shin, Dongseong, additional, Park, Min Kyu, additional, Hwang, Jun Gi, additional, Kim, Min-Gul, additional, Chung, Hyewon, additional, Ghim, JongLyul, additional, Chung, Jae-Yong, additional, Smolen, Josef S., additional, Burmester, Gerd R., additional, Kim, SungHyun, additional, Bae, YunJu, additional, Jeon, DaBee, additional, Yoo, JaeKyoung, additional, Yang, GoEun, additional, Bae, JiHun, additional, and Keystone, Edward, additional

Published
2023
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8. Su1779 SUBCUTANEOUS INFLIXIMAB (CT-P13 SC) FOR ULCERATIVE COLITIS: 2-YEAR EXTENSION RESULTS OF THE LIBERTY-UC STUDY

Author

Sandborn, William J., Sands, Bruce E., Hanauer, Stephen B., Colombel, Jean Frederic, Schreiber, Stefan, Danese, Silvio, Klopocka, Maria, Kulynych, Roman, Kierkus, Jaroslaw, Soltysiak, Artur, Smolinski, Patryk, Gonciarz, Maciej, Sreckovic, Slobodan, Valuyskikh, Ekaterina, Horynski, Marek, Gasbarrini, Antonio, Lee, Sang Joon, Kim, Sung Hyun, Bae, Yunju, Lee, Sunhee, Lee, Seul Gi, Lee, Joon Ho, Kim, Jong Min, and Lee, Ji Min

Published
2024
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9. Su1762 SUBCUTANEOUS INFLIXIMAB (CT-P13 SC) AS MAINTENANCE THERAPY FOR CROHN'S DISEASE: 2 YEARS RESULTS OF THE LIBERTY-CD STUDY

Author

Hanauer, Stephen B., Colombel, Jean Frederic, Sandborn, William J., Sands, Bruce E., Schreiber, Stefan, Danese, Silvio, Kierkus, Jaroslaw, Kulynych, Roman, Klopocka, Maria, Lahat, Adi, Gonciarz, Maciej, Osipenko, Marina, Borzan, Vladimir, Kowalski, Maciej, Saenko, Daria V., Sardinov, Ruslan, Lee, Sang Joon, Kim, Sung Hyun, Bae, Yunju, Lee, Sunhee, Lee, Seul Gi, Yang, Siyoung, Lee, Juhyun, and Park, Gahee

Published
2024
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10. Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study

Author

Park, Won, Yoo, Dae Hyun, Miranda, Pedro, Brzosko, Marek, Wiland, Piotr, Gutierrez-Ureña, Sergio, Mikazane, Helena, Lee, Yeon-Ah, Smiyan, Svitlana, Lim, Mie-Jin, Kadinov, Vladimir, Abud-Mendoza, Carlos, Kim, HoUng, Lee, Sang Joon, Bae, YunJu, Kim, SuYeon, and Braun, Jürgen

Published
2017
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11. Tu1701 SUBCUTANEOUS INFLIXIMAB (CT-P13 SC) AS MAINTENANCE THERAPY FOR ULCERATIVE COLIITS: A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED STUDY: RESULTS OF THE LIBERTY-UC STUDY

Author

Sandborn, William J., Sands, Bruce E., Hanauer, Stephen B., Colombel, Jean Frederic, Schreiber, Stefan, Danese, Silvio, Klopocka, Maria, Kulynych, Roman, Kierkus, Jaroslaw, Soltysiak, Artur, Smolinski, Patryk, Gonciarz, Maciej, Sreckovic, Slobodan, Valuyskikh, Ekaterina, Horynski, Marek, Gasbarrini, Antonio, Kim, Sung Hyun, Bae, Yunju, Lee, Sunhee, Lee, Joon Ho, Lee, Ji Min, Lee, Sang Joon, Lee, Seul Gi, and Kim, Jong Min

Published
2023
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12. 1028 SUBCUTANEOUS INFLIXIMAB (CT-P13) AS MAINTENANCE THERAPY FOR CROHN'S DISEASE: A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED STUDY (LIBERTY-CD).

Author

Hanauer, Stephen B., Colombel, Jean Frederic, Sandborn, William J., Sands, Bruce E., Schreiber, Stefan, Danese, Silvio, Kierkus, Jaroslaw, Kulynych, Roman, Klopocka, Maria, Lahat, Adi, Gonciarz, Maciej, Osipenko, Marina, Borzan, Vladimir, Kowalski, Maciej, Saenko, Daria V., Sardinov, Ruslan, Kim, Sung Hyun, Bae, Yunju, Lee, Sunhee, Yang, Siyoung, Lee, Juhyun, Lee, Sang Joon, Lee, Seul Gi, and Park, Gahee

Published
2023
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14. Comparison of Efficacy and Safety of Biosimilar CT-P10 to Rituximab in Patients with Previously Untreated Low Tumor Burden Follicular Lymphoma (LTBFL): A Randomized Phase III Study

Author

Ogura, Michinori, primary, Sancho, Juan Manuel, additional, Cho, Seok-Goo, additional, Nakazawa, Hideyuki, additional, Suzumiya, Junji, additional, Tumyan, Gayane, additional, Kim, Jin Seok, additional, Lennard, Anne, additional, Mariz, Jose Mario, additional, Ilyin, Nikolai, additional, Jurczak, Wojciech, additional, Martinez, Aurelio Lopez, additional, Samoilova, Olga, additional, Zhavrid, Edvard, additional, Ruiz, Eduardo Yanez, additional, Trneny, Marek, additional, Popplewell, Leslie, additional, Coiffier, Bertrand, additional, Buske, Christian, additional, Kim, Won Seog, additional, Lee, SangJoon, additional, Lee, Sungyoung, additional, Bae, YunJu, additional, and Kwak, Larry W, additional

Published
2018
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15. Double-blind, randomized phase 3 study to compare efficacy and safety of the biosimilar CT-P10 to rituximab combined with CVP therapy in patients with previously untreated advanced-stage follicular lymphoma.

Author

Kim, Won Seog, primary, Jurczak, Wojciech, additional, Sancho, Juan-Manuel, additional, Javrid, Edvard, additional, Kim, Jin Seok, additional, Hernandez Rivas, Jose Angel, additional, Prokharau, Aliaksandr, additional, Vasilica, Mariana, additional, Nagarkar, Rajnish, additional, Osmanov, Dzhelil, additional, Buske, Christian, additional, Kwak, Larry, additional, Ogura, Michinori, additional, Lee, Sang Joon, additional, Lee, Sung Young, additional, Bae, Yunju, additional, and Coiffier, Bertrand, additional

Published
2017
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16. Efficacy and safety of switching from reference infliximab to CT-P13 compared with maintenance of CT-P13 in ankylosing spondylitis: 102-week data from the PLANETAS extension study

Author

Park, Won, primary, Yoo, Dae Hyun, additional, Miranda, Pedro, additional, Brzosko, Marek, additional, Wiland, Piotr, additional, Gutierrez-Ureña, Sergio, additional, Mikazane, Helena, additional, Lee, Yeon-Ah, additional, Smiyan, Svitlana, additional, Lim, Mie-Jin, additional, Kadinov, Vladimir, additional, Abud-Mendoza, Carlos, additional, Kim, HoUng, additional, Lee, Sang Joon, additional, Bae, YunJu, additional, Kim, SuYeon, additional, and Braun, Jürgen, additional

Published
2016
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19. Toxic effects of mercuric sulfide on immune organs in mice

Author

Son, Hee-Young, primary, Lee, Soyoung, additional, Park, Seung-Bin, additional, Kim, Mi-Sun, additional, Choi, Eun-Ju, additional, Singh, Thoudam S.K., additional, Bae, Yunju, additional, Kwack, Seung Jun, additional, Kang, Tae Seok, additional, Shin, Hong-In, additional, Baek, Moon-Chang, additional, and Kim, Sang-Hyun, additional

Published
2009
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20. Toxic effects of mercuric sulfide on immune organs in mice.

Author

Son, Hee-Young, Lee, Soyoung, Park, Seung-Bin, Kim, Mi-Sun, Choi, Eun-Ju, Singh, Thoudam S.K., Bae, Yunju, Kwack, Seung Jun, Kang, Tae Seok, Shin, Hong-In, Baek, Moon-Chang, and Kim, Sang-Hyun

Subjects
CINNABAR, MICE, SUBSTANCE abuse, IMMUNITY, FOOD consumption, HEPATOTOXICOLOGY, HYPERPLASIA
Abstract

Mercuric sulfide (HgS) is a major component of cinnabar, which has been used as a sedative drug in China for more than 2000 years. Because its toxicological effects are still unclear, we attempted to verify the toxic effects of HgS, focused on liver and immune organs such as the spleen and thymus. Male ICR mice were administered HgS (0.02, 0.2, 2.0 g/kg/day) by gavage for 4 weeks. During the administration period, HgS-treated mice did not reveal overt signs of clinical toxicity. HgS had no significant effect on body weight, food consumption, water consumption, and organ weights. In spite of its known insolubility, HgS was absorbed by the gastrointestinal tract and accumulated in the liver, spleen and thymus in a dose-dependent manner. In the biochemical and histological examination, HgS did not cause hepatotoxicity. However, HgS significantly increased both CD8+ T lymphocytes and CD4+CD8+ lymphocyte populations in the spleen without changing in the thymus. In the histological evaluation, HgS induced enlargement with marked hyperplasia and increase of lymphoid follicles in the spleen. In addition, HgS induced the gene expression of pro-inflammatory cytokines in the spleen and thymus. Our results suggest that insoluble HgS was absorbed by the gastrointestinal tract, accumulated in the spleen and thymus, and thus could affect immune systems. [ABSTRACT FROM AUTHOR]

Published
2010
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