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713 results on '"Zhou, Honghui"'

201. Target-Mediated Drug Disposition of Daratumumab Following Intravenous Infusion in Relapsed or Refractory Multiple Myeloma after Prior Proteasome Inhibitors and Immunomodulatory Drugs: A Population Pharmacokinetic Analysis

Author

Yan, Xiaoyu, primary, Clemens, Pamela L, additional, Puchalski, Thomas, additional, Lonial, Sagar, additional, Lokhorst, Henk M., additional, Orlowski, Robert Z., additional, Losic, Nedjad, additional, Khan, Imran, additional, Jansson, Richard, additional, Ahmadi, Tahamtan, additional, Lantz, Kristen, additional, Perez Ruixo, Juan Jose, additional, Zhou, Honghui, additional, and Xu, Xu Steven, additional

Published
2015
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207. Mo1215 Serum Golimumab Exposure and the Incidence of Selected Safety Events in Patients With Ulcerative Colitis Following Treatment With Golimumab: An Exploratory Analysis of the PURSUIT Study Data

Author

Adedokun, Omoniyi J., primary, Xu, Zhenhua, additional, Marano, Colleen W., additional, Strauss, Richard, additional, Zhang, Hongyan, additional, Johanns, Jewel, additional, Zhou, Honghui, additional, Davis, Hugh M., additional, Liao, Sam, additional, Colombel, Jean-Frederic, additional, Reinisch, Walter, additional, Feagan, Brian G., additional, Rutgeerts, Paul J., additional, Gibson, Peter R., additional, and Sandborn, William, additional

Published
2014
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210. The cocktail approach and its utility in drug-drug interaction assessments for therapeutic proteins

Author

Zhou, Honghui, Zhou, H ( Honghui ), Jetter, Alexander, Fuhr, Uwe, Zhou, Honghui, Zhou, H ( Honghui ), Jetter, Alexander, and Fuhr, Uwe

Abstract

This chapter demonstrates that the cocktail approach is suitable for the study of interactions between therapeutic proteins and drugs in humans—namely for the study of the effect of therapeutic proteins on cytochrome P450 enzyme activities.This is the area in which the FDA's current draft guideline on drug interaction studies recommends the use of cocktail phenotyping studies as an alternative to individual therapeutic protein–drug interaction studies.

Published
2013

213. A Novel Approach to Evaluate the Pharmacokinetic Biocomparability of a Monoclonal Antibody Derived from Two Different Cell Lines Using Simultaneous Crossover Design

Author

Han, Chao, primary, McIntosh, Thomas S., additional, Geist, Brian J., additional, Jiao, Trina, additional, Puchalski, Thomas A., additional, Goldberg, Kenneth M., additional, Yang, Tong-Yuan, additional, Pendley, Charles E., additional, Zhou, Honghui, additional, and Davis, Hugh M., additional

Published
2013
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214. A phase 1, randomized study to assess the pharmacokinetic comparability of siltuximab derived from two different cell lines in healthy subjects

Author

Xu, Chao, primary, Han, Chao, additional, Marini, Joseph, additional, Ford, Joyce, additional, Marciniak, Stanley, additional, Lopez, Manny, additional, Frederick, Bart, additional, de Vries, Dick, additional, Bandekar, Rajesh, additional, Davis, Hugh M., additional, Zhou, Honghui, additional, and Puchalski, Thomas A., additional

Published
2013
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216. Effects of Immunomodulators on the Pharmacokinetics and Efficacy of Golimumab in Patients with Moderately to Severely Active Ulcerative Colitis: Results from Phase 2/3 PURSUIT-SC Induction and Maintenance Studies

Author

Adedokun, Omoniyi, primary, Xu, Zhenhua, additional, Marano, Colleen, additional, Strauss, Richard, additional, Zhang, Hongyan, additional, Johanns, Jewel, additional, Ford, Joyce, additional, Zhou, Honghui, additional, Davis, Hugh, additional, Colombel, Jean-Frederic, additional, Reinisch, Walter, additional, Feagan, Brian, additional, Rutgeerts, Paul, additional, and Sandborn, William, additional

Published
2013
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220. Monographs for Drug-Drug Interactions of Therapeutics Biologics

Author

Leu, Jocelyn, primary, Kasek, Simone, additional, Li, Christine, additional, Limothai, Wararat, additional, Madhura, Dora Babu, additional, Rathi, Chetan, additional, Rawal, Sumit, additional, Ryman, Josiah, additional, Thomson, Margaret, additional, Trivedi, Ashit, additional, Zhou, Honghui, additional, and Meibohm, Bernd, additional

Published
2013
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223. Sa1203 Pharmacokinetics and Exposure-Response Relationship of Golimumab in Patients With Moderately to Severely Active Ulcerative Colitis: Results From Phase2/3 Induction and Maintenance Studies

Author

Adedokun, Omoniyi J., primary, Xu, Zhenhua, additional, Marano, Colleen W, additional, Strauss, Richard, additional, Zhang, Hongyan, additional, Johanns, Jewel, additional, Ford, Joyce A., additional, Zhou, Honghui, additional, Davis, Hugh M., additional, Colombel, Jean-Frederic, additional, Reinisch, Walter, additional, Feagan, Brian G., additional, Rutgeerts, Paul J., additional, and Sandborn, William, additional

Published
2013
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224. Pharmacokinetics and safety of sirukumab following a single subcutaneous administration to healthy Japanese and Caucasian subjects

Author

Zhuang, Yanli, primary, Xu, Zhenhua, additional, Vries, Dick E. de, additional, Wang, Qingmin, additional, Shishido, Akira, additional, Comisar, Craig, additional, Ford, Joyce A., additional, Keen, Monica, additional, Achira, Meguru, additional, Tsukamoto, Yuko, additional, Petty, Kevin J., additional, Davis, Hugh M., additional, and Zhou, Honghui, additional

Published
2013
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225. Evaluation of Disease-Mediated Therapeutic Protein-Drug Interactions Between an Anti-Interleukin-6 Monoclonal Antibody (Sirukumab) and Cytochrome P450 Activities in a Phase 1 Study in Patients With Rheumatoid Arthritis Using a Cocktail Approach.

Author

Zhuang, Yanli, de Vries, Dick E., Xu, Zhenhua, Marciniak, Stanley J., Chen, Dion, Leon, Francisco, Davis, Hugh M., and Zhou, Honghui

Subjects
THERAPEUTIC use of monoclonal antibodies, C-reactive protein, CAFFEINE, CLINICAL trials, DRUG interactions, INTERLEUKINS, MIDAZOLAM, MONOCLONAL antibodies, OMEPRAZOLE, ORAL drug administration, RHEUMATOID arthritis, VITAMIN K, WARFARIN, CYTOCHROME P-450
Abstract

This therapeutic protein-drug interaction study evaluated the disease-mediated effect of sirukumab (anti-interleukin 6 [anti-IL-6] monoclonal antibody) on the pharmacokinetics of the cytochrome P450 (CYP) probe substrates midazolam (CYP3A), omeprazole (CYP2C19), warfarin (CYP2C9), and caffeine (CYP1A2) in patients with active rheumatoid arthritis (RA). Twelve patients with C-reactive protein (CRP) ≥ 8.0 mg/L at screening received oral administration of a CYP probe cocktail consisting of 0.03 mg/kg midazolam, 10 mg warfarin + 10 mg vitamin K (equivalent to 5mg S-warfarin), 20mgomeprazole, and 100mg caffeine 1 week before and 1, 3, and 6 weeks after a single subcutaneous dose of 300 mg sirukumab. The results showed that the pharmacokinetics of midazolam, omeprazole, and S-warfarin were nonequivalent before and after the administration of a single dose of 300mg sirukumab. Area under the plasma concentration-time curve (AUC0-∞) for midazolam, omeprazole, and S-warfarin was reduced by 30%-35%, 37%-45%, and 18%-19%, respectively, after sirukumab administration. Caffeine AUC0-∞ was increased by 20%-34% after sirukumab administration. The effect of sirukumabon CYP substrates was sustained for at least 6 weeks. No new adverse drug reactions related to the administration of sirukumab were observed in this study. These results suggest that sirukumab may reverse IL-6-mediated suppression of CYP3A, CYP2C9, and CYP2C19 activities in patients with active RA. [ABSTRACT FROM AUTHOR]

Published
2015
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226. Non-Clinical Pharmacokinetics, Prediction of Human Pharmacokinetics and First-in-Human Dose Selection for CNTO 5825, an Anti-Interleukin-13 Monoclonal Antibody.

Author

Nnane, Ivo P., Xu, Zhenhua, Zhou, Honghui, and Davis, Hugh M.

Subjects
PHARMACOKINETICS, INTERLEUKIN-13, THERAPEUTIC use of monoclonal antibodies, DRUG side effects, DRUG bioavailability, DRUG toxicity
Abstract

CNTO 5825 is a human anti-interleukin-13 ( IL-13) monoclonal antibody (m Ab) that inhibits binding of human IL-13 to IL-13Rα1 and IL-13Rα2. The purpose of this investigation was to predict human pharmacokinetics ( PK) of CNTO 5825 using different allometric approaches and non-clinical PK data in order to select the right and safe doses for first-in-human ( FIH) study. After intravenous ( IV) administration of CNTO 5825, clearance ( CL) ranged from 9.98 to 11.49 ml/day/kg in rats and from 5.78 to 7.19 ml/day/kg in cynomolgus monkeys. The volume of distribution at steady-state (Vss) in rats was large (151.52-155.64 ml/kg) compared to cynomolgus monkey (49.77-61.10 ml/kg). The terminal half-life ( T1/2) ranged from 12.29 to 14.15 days in rats and from 6.61 to 7.73 days in cynomolgus monkeys. The PK of CNTO 5825 was linear in 1-10 mg/kg dose range in both species. The bioavailability after subcutaneous ( SC) administration was 94% and 79% in rats and cynomolgus monkeys, respectively. The predicted CL and Vss based on allometric methods and PK data from rats and monkeys were within twofold of observed CL and Vss in human beings; the predicted CL and Vss in human beings (70 kg) based on time-invariant method with combined PK data from rats and monkeys were 4.84 ± 1.13 ml/day/kg and 68.93 ± 35.55 ml/kg, respectively. The selected doses for the FIH study based on time-invariant method and no observed adverse effect level in toxicity studies in rats and monkeys provided exposures that were subsequently shown to be well tolerated and safe in human beings. [ABSTRACT FROM AUTHOR]

Published
2015
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227. A New Class of Room‐Temperature Multiferroic Thin Films with Bismuth‐Based Supercell Structure

Author

Chen, Aiping, primary, Zhou, Honghui, additional, Bi, Zhenxing, additional, Zhu, Yuanyuan, additional, Luo, Zhiping, additional, Bayraktaroglu, Adrian, additional, Phillips, Jamie, additional, Choi, Eun‐Mi, additional, MacManus‐Driscoll, Judith L., additional, Pennycook, Stephen J., additional, Narayan, Jagdish, additional, Jia, Quanxi, additional, Zhang, Xinghang, additional, and Wang, Haiyan, additional

Published
2012
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228. Population Pharmacokinetic and Pharmacodynamic Modeling of an Anti–Interleukin-6 Chimeric Monoclonal Antibody, Siltuximab (CNTO 328), in Patients with B-Cell Non-Hodgkin's Lymphoma, Multiple Myeloma, or Castleman's Disease

Author

Xie, Lanyi, primary, Li, Lilian Y, additional, Kurzrock, Razelle, additional, van Rhee, Frits, additional, Qin, Xiang, additional, Reddy, Manjula, additional, Qi, Ming, additional, Davis, Hugh M, additional, Zhou, Honghui, additional, and Puchalski, Thomas A, additional

Published
2012
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230. Development of the IL‐12/23 antagonist ustekinumab in psoriasis: past, present, and future perspectives – an update

Author

Yeilding, Newman, primary, Szapary, Philippe, additional, Brodmerkel, Carrie, additional, Benson, Jacqueline, additional, Plotnick, Michael, additional, Zhou, Honghui, additional, Goyal, Kavitha, additional, Schenkel, Brad, additional, Giles‐Komar, Jill, additional, Mascelli, Mary Ann, additional, and Guzzo, Cynthia, additional

Published
2012
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232. Sa1989 Pharmacokinetics of Infliximab in Pediatric Patients With Moderate to Severe Ulcerative Colitis: Results From a Randomized, Multicenter, Open-Label Phase 3 Study

Author

Adedokun, Omoniyi J., primary, Xu, Zhenhua, additional, Damaraju, Lakshmi, additional, Blank, Marion, additional, Johanns, Jewel, additional, Griffiths, Anne M., additional, Ford, Joyce A., additional, Zhou, Honghui, additional, Guzzo, Cynthia A., additional, Davis, Hugh M., additional, and Hyams, Jeffrey S., additional

Published
2012
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233. Abstract 2518: A novel preclinical study in cynomolgus monkeys examining CCL2 production rate and kinetic profile after escalating dose administration of anti-CCL2 human monoclonal antibody carlumab (CNTO 888)

Author

Puchalski, Thomas, primary, Han, Chao, additional, McIntosh, Thomas, additional, Brenner, Erik, additional, Fink, Damien, additional, Graham, Kenneth, additional, Jiao, Qun, additional, Seetharam, Shobha, additional, Takimoto, Chris, additional, Davis, Hugh, additional, and Zhou, Honghui, additional

Published
2012
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235. Golimumab Pharmacokinetics After Repeated Subcutaneous and Intravenous Administrations in Patients with Rheumatoid Arthritis and the Effect of Concomitant Methotrexate: An Open-Label, Randomized Study

Author

Zhuang, Yanli, primary, Xu, Zhenhua, additional, Frederick, Bart, additional, de Vries, Dick E., additional, Ford, Joyce A., additional, Keen, Monica, additional, Doyle, Mittie K., additional, Petty, Kevin J., additional, Davis, Hugh M., additional, and Zhou, Honghui, additional

Published
2012
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241. AAPS Workshop Report: Strategies to Address Therapeutic Protein–Drug Interactions during Clinical Development

Author

Girish, Sandhya, primary, Martin, Steven W, additional, Peterson, Mark C, additional, Zhang, Lei K., additional, Zhao, Hong, additional, Balthasar, Joseph, additional, Evers, Raymond, additional, Zhou, Honghui, additional, Zhu, Min, additional, Klunk, Lewis, additional, Han, Chao, additional, Berglund, Eva Gil, additional, Huang, Shiew-Mei, additional, and Joshi, Amita, additional

Published
2011
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