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Publications

Pharmacokinetics and PK/PD

Zhang, X., Goel, V., et al. Pharmacokinetics of patisiran, the first approved RNA interference (RNAi) therapy, in patients with hereditary transthyretin-mediated amyloidosis. J Clin Pharmacol. 2020;60(5):573–585.https://accp1.onlinelibrary.wiley.com/doi/epdf/10.1002/jcph.1553
Zhang, X., Goel, V., et al. Patisiran pharmacokinetics, pharmacodynamics, and exposure–response analyses in the phase 3 APOLLO trial, in patients with hereditary transthyretin-mediated (hATTR) amyloidosis. J Clin Pharmacol.2020;60(1):37-49. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6972979/pdf/JCPH-60-37.pdf
Abdallah, H., …, Zhang, X., et al. Pharmacokinetic and pharmacodynamic analysis of subcutaneous tocilizumab in patients with rheumatoid arthritis from two randomized controlled trials: SUMMACTA and BREVACTA. J Clin Pharmacol.2017;57(4):459-468. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5363244/pdf/JCPH-57-459.pdf
Zhang, X., Chen, Y-C., et al.Clinical pharmacology of tocilizumab for the treatment of polyarticular-course juvenile idiopathic arthritis. Expert Rev Clin Pharmacol. 2017;10(5):471-482. https://www.tandfonline.com/doi/abs/10.1080/17512433.2017.1300058
Zhang, X., Imel, E. et al. Pharmacokinetics and pharmacodynamics of a human monoclonal anti-FGF23 antibody (KRN23) in the first multiple ascending-dose trial treating adults with X-linked hypophosphatemia. J Clin Pharmacol. 2016;56(2):176-85. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5042055/pdf/JCPH-56-176.pdf
Zhang, X., Chen, Y-C., et al.Pharmacokinetics and pharmacodynamics of tocilizumab after subcutaneous administration in patients with rheumatoid arthritis. Int J Clin Pharmacol Ther. 2013;51(8); 620-630 2013. https://pubmed.ncbi.nlm.nih.gov/23782588/
Zhang, X., Georgy, A., et al. Pharmacokinetics and pharmacodynamics of tocilizumab, a humanized anti-interleukin-6 receptor monoclonal antibody, following single-dose administration by subcutaneous and intravenous routes to healthy subjects. Int J Clin Pharmacol Ther. 2013;51(6);443-455. https://pubmed.ncbi.nlm.nih.gov/23547848/
Morcos, P., Zhang, X., et al. Pharmacokinetics, and pharmacodynamics of single subcutaneous doses of tocilizumab administered with or without rHuPH20 in healthy volunteers. Int J Clin Pharmacol Ther. 2013;51(7); 537-548. https://pubmed.ncbi.nlm.nih.gov/23547849/
Zhang, X., Morcos, P., et al. Clinical pharmacology of tocilizumab for the treatment of patients with systemic juvenile idiopathic arthritis. Expert Rev Clin Pharmacol. 2013;6(2), 123–137. https://pubmed.ncbi.nlm.nih.gov/23473591/
Zhang, X., Peck, R. Clinical pharmacology of tocilizumab for the treatment of patients with rheumatoid arthritis. Expert Rev Clin Pharmacol.2011;4(5):539–558. https://www.tandfonline.com/doi/abs/10.1586/ecp.11.33
Lalezari, J. P, Patel, I. H., Zhang, X., et al. Influence of subcutaneous injection site on the steady-state pharmacokinetics of enfuvirtide (T-20) in HIV-1-infected patients. J Clin Virol.2003;28(2):217-22. https://accp1.onlinelibrary.wiley.com/doi/abs/10.1177/0091270003259220
Zhang, X., Mehvar, R. Dextran-methylprednisolone succinate as a prodrug of methylprednisolone: plasma and tissue disposition. J Pharm Sci. 2001; 90(12):2078-2087. https://pubmed.ncbi.nlm.nih.gov/11745766/
Zhang, X., Mehvar, R. Dextran-methylprednisolone succinate as a prodrug of methylprednisolone: dose-dependent pharmacokinetics in rats. Int J Pharm. 2001; 229(1-2):173-82. https://pubmed.ncbi.nlm.nih.gov/11604270/
Mehvar, R., Zhang, X. Development and application of an isolated perfused rat liver model to study the stimulation and inhibition of tumor necrosis factor-alpha production ex vivo. Pharm Res. 2002;19(1):47-53. https://pubmed.ncbi.nlm.nih.gov/11837700/
Zhang, X., Fettner, S., et al. Metabolism and excretion of a novel p38 MAP kinase inhibitor pamapimod in healthy male subjects. Int. J Clin Pharmacol Ther, 2011;49(6): 345-352. https://pubmed.ncbi.nlm.nih.gov/21612741/

Population PK/PD Modeling

Goel,V., …, Zhang, X., et al. Population Pharmacokinetic–Pharmacodynamic Model of Serum Transthyretin Following Patisiran Administration. Nucleic Acid Therapeutics.2020;30(3):143-152. https://www.liebertpub.com/doi/10.1089/nat.2019.0841
Zhang, X., Peyret, T., et al. Population pharmacokinetic and pharmacodynamic analyses from a 4-month intradose escalation and its subsequent 12-month dose titration studies for a human monoclonal anti-FGF23 antibody (KRN23) in adults with X-linked hypophosphatemia. J Clin Pharmacol. 2016;56(4):429-348. https://accp1.onlinelibrary.wiley.com/doi/10.1002/jcph.611
Zhang, X., Lin, T., et al. Population pharmacokinetics of enfuvirtide in HIV-1-infected pediatric patients over 48 weeks of treatment. J Clin Pharmacol.2007;47(4):510-517. https://accp1.onlinelibrary.wiley.com/doi/abs/10.1177/0091270006299089
Mould, D. R., Zhang, X., et al. Population pharmacokinetics and exposure-response relationship of enfuvirtide in treatment-experienced human immunodeficiency virus type 1-infected patients. Clin Pharmacol Ther. 2005;77(6):515-528.https://ascpt.onlinelibrary.wiley.com/doi/abs/10.1016/j.clpt.2005.02.005
Zhang, X., Nieforth, K., et al. Pharmacokinetics of plasma enfuvirtide after subcutaneous administration to patients with immunodeficiency virus: Inverse Gaussian Density absorption and 2-compartment disposition. Clin Pharmacol Ther. 2002;72(1):10-19. https://ascpt.onlinelibrary.wiley.com/doi/abs/10.1067/mcp.2002.125945

Drug-Drug Interaction

Mukai, M., Uchimura, T., …, Zhang, X., et al. Effects of rifampin on the pharmacokinetics of a single dose of istradefylline in healthy subjects. J Clin Pharmacol. 2018;58(2): 193-201.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5811788/pdf/JCPH-58-193.pdf
Boyd, M. A., Zhang, X., et al.Lack of enzyme-inducing effect of rifampicin on the pharmacokinetics of enfuvirtide. J Clin Pharmacol. 2003;43(12):1382-1391.
Ruxrungtham, K., Boyd, M.,…, Zhang, X., et al. Lack of Interaction between enfuvirtide and ritonavir or ritonavir-boosted saquinavir in HIV-1-infected patients. J Clin Pharmacol. 2004;44(7):793-803.https://accp1.onlinelibrary.wiley.com/doi/abs/10.1177/0091270004266489
Zhang, X., Lalezari, J. P., et al. Assessment of drug-drug interaction potential of enfuvirtide in human immunodeficiency virus type 1-infected patients. Clin Pharmacol Ther.2004;75(6):558-568. https://ascpt.onlinelibrary.wiley.com/doi/abs/10.1016/j.clpt.2004.02.003
Patel, I. H., Zhang, X., et al. Pharmacokinetics, pharmacodynamics and drug Interaction potential of enfuvirtide. Clin Pharmacokinet. 2005;44(2):175-186.https://pubmed.ncbi.nlm.nih.gov/15656696/
Jamois, C., Smith, P., …, Zhang, X.. Effect of saquinavir/ritonavir (1000/100 mg bid) on the pharmacokinetics of methadone in opiate-dependent HIV-negative patients on stable methadone maintenance therapy.Addiction Biology. 2009;14(3):321-327. https://onlinelibrary.wiley.com/doi/10.1111/j.1369-1600.2009.00158.x
Kaeser, K., Zandt, H., …, Zhang, X. Drug-drug interaction study of ketoconazole and ritonavir-boosted saquinavir. Antimicrob Agents Chemother. 2009;53(2):609–614. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2630604/pdf/0769-08.pdf
Schmitt, C., Kuhn, B., Zhang, X., et al. Tocilizumab has no clinically relevant effects on methotrexate pharmacokinetics in patients with rheumatoid arthritis. Int J Clin Pharmacol Ther. 2011;50(3):218-223. https://pubmed.ncbi.nlm.nih.gov/22373834/
Schmitt, C., Kuhn, B., Zhang, X., et al. Disease-drug-drug interaction involving tocilizumab and simvastatin in patients with rheumatoid arthritis. Clin Pharmacol Ther. 2011;89(5):735-740. https://ascpt.onlinelibrary.wiley.com/doi/10.1038/clpt.2011.35
Zhang, X., Fettner, S., Zwanziger, E.et al. Pharmacokinetic interaction study of ritonavir-boosted saquinavir in combination with rifabutin in healthy subjects. Antimicrob Agents Chemother. 2011;55(2):680–687. https://journals.asm.org/doi/10.1128/AAC.00992-10
Zhang, X., Rowell, L., et al. Assessment of disease-drug-drug interaction between single-dose tocilizumab and oral contraceptives in women with active rheumatoid arthritis. Int J Clin Pharmacol Ther. 2014;52(1):27-38. https://pubmed.ncbi.nlm.nih.gov/24161161/

Thorough QT/QTc Study

Zhang, X., Silkey, M., Schumacher, M., et al. Period correction of the QTc of moxifloxacin with multiple predose baseline ECGs is the least variable of 4 methods tested. J Clin Pharmacol.2009;49(5):534-539. https://accp1.onlinelibrary.wiley.com/doi/abs/10.1177/0091270008330158
Grange, S., Schmitt, C., …,Zhang, X. Thorough QT/QTc study of tocilizumab after single-dose administration at therapeutic and supratherapeutic doses in healthy subjects. Int J Clin Pharmacol Ther.2011;49(11):648-655. https://pubmed.ncbi.nlm.nih.gov/22011689/
Zhang, X., Jordan, P., et al. Thorough QT/QTc study ebof ritonavir-boosted saquinavir following multiple-dose administration of therapeutic and supratherapeutic doses in healthy participants. J Clin Pharmacol. 2012;52(4):520-529. https://doi.org/10.1177/0091270011400071

Clinical Trials

Yamashita, T., Ueda, M.,…, Zhang, X., et al.Patisiran, an RNAi therapeutic for patients with hereditary transthyretin-mediated amyloidosis: Sub-analysis in Japanese patients from the APOLLO study. Neurol Clin Neurosci. 2020;8:251–260. https://onlinelibrary.wiley.com/doi/epdf/10.1111/ncn3.12396
Judge, D. P., Kristen, A.V., …, Zhang, X., et al.Phase 3 multicenter study of revusiran in patients with hereditary transthyretin-mediated (hATTR) amyloidosis with cardiomyopathy (ENDEAVOUR). Cardiovas Drugs Ther. 2020;34(3):357-370. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7242280/pdf/10557_2019_Article_6919.pdf
Mahadevan, D., Lanasa, M.C., …, Zhang, X., et al. Phase I study of samalizumab in chronic lymphocytic leukemia and multiple myeloma: Blockade of the immune checkpoint CD200.J Immunother Cancer. 2019;7(1):227. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6708181/pdf/40425_2019_Article_710.pdf
Sarantopoulos, J., Mita, M.M.,…, Zhang, X., et al. Phase 1 study of monotherapy with KHK2866, an anti-heparin-binding epidermal growth factor-like growth factor monoclonal antibody, in patients with advanced cancer. Targeted Oncology. 2016;11:317-327. https://link.springer.com/article/10.1007/s11523-015-0394-5
Duvic, M., Pinter-Brown,L.C., Zhang, X.,…, et al. Phase I/II study of mogamulizumab (KW-0761), a defucosylated anti-CCR4 antibody, in previously treated patients with cutaneous or peripheral T-cell lymphoma. Blood. 2015;125(2):1883-1889.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4375715/?report=printable
Imel, E. A., Zhang, X., Ruppe, M.D., et al. Prolonged correction of serum phosphorus in adults with X-linked hypophosphatemia using monthly doses of KRN23. J Clin Endocrinol Metab.2015;100(7):2565-2573. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4495171/?report=printable
Carpenter, T. O.,…, Zhang, X., et al. Randomized trial of the anti-FGF23 antibody KRN23 in X-linked hypophosphatemia. J Clin Invest. 2014;124(4):1587-97.https://www.jci.org/articles/view/72829/pdf
Ruppe, M. D., Zhang, X., Imel, E.A., et al. Effect of four monthly doses of a human monoclonal anti-FGF23 antibody (KRN23) on quality of life in X-linked hypophosphatemia. Bone Reports. 2016;5:158–162.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4926842/pdf/main.pdf
Zhang, X., Huang, Y., Navarro, M.T., et al. A Proof-of-concept and drug-drug interaction study of pamapimod, a novel p38 MAP kinase inhibitor, with methotrexate in patients with rheumatoid arthritis. J. Clin Pharmacol. 2010;50(9):1031-1038. https://accp1.onlinelibrary.wiley.com/doi/10.1177/0091270009357433

Patents

Zhang, X., Terao, K., Jahreis, A. M., Bao, M. Subcutaneously Administered Anti-IL-6 Receptor Antibody. Assigned to Hoffmann-La Roche Inc, Genentech Inc., and Chugai Seiyaku Kabushiki Kaisha. Pub. No.: US 2021/0228597 A1. Pub. Date: Jul. 29, 2021.
Zhang, X., Terao, K. Subcutaneously Administered Anti-IL-6 Receptor Antibody. Assigned to Hoffmann-La Roche Inc and Chugai Seiyaku Kabushiki Kaisha. Patent No.: US 10,874,677 B2 Date of Patent: Dec. 29, 2020.
Zhang, X., Terao, K., Harari, O. A. Subcutaneously Administered Anti-IL-6 Receptor Antibody for treatment of Juvenile idiopathic Arthritis. Assigned to Hoffmann-La Roche Inc and Chugai Seiyaku Kabushiki Kaisha. Patent No. US 10,231,981 B2. Date of Patent: Mar. 19, 2019.
Zhang, X., Pan, W. J. “Method of Treating Acute Myeloid Leukemia (AML) with combinations of anti-CD200 antibodies, cytarabine, and daunorubicin”. International Publication No.: WO 2018/075 408 A1. International Publication Date: 26 April 2018.
Zhang, X., Pan, W. J. “Method of Treating Solid tumor with anti-CD200 antibodies”. Assigned to Alexion Pharmaceuticals Inc. International Publication No.: WO 2018/102594 A1. International Publication Date: 07 June 2018.
Zhang, X., Terao, K, Harari, O. A. Subcutaneously Administered Anti-IL-6 Receptor Antibody for treatment of Juvenile idiopathic Arthritis. Assigned to Hoffmann-La Roche Inc and Chugai Seiyaku Kabushiki Kaisha. Patent No.: US 9,750,752 B2. Date of Patent: Sept 5, 2017.
Zhang, X., Terao, K., Jahreis, A. Subcutaneously Administered Anti-IL-6 Receptor Antibody for treatment of Systemic Sclerosis. Assigned to Hoffmann-La Roche Inc., Genentech Inc., and Chugai Seiyaku Kabushiki Kaisha. Patent No. US 9,539,263 B2. Date of patent: Jan. 10, 2017
Zhang, X., Terao, K., Harari, O. A. Subcutaneously Administered Anti-IL-6 Receptor Antibody. Assigned to Hoffmann-La Roche Inc and Chugai Pharmaceutical Inc. Pub. No.: US 2014/0056883 A1. Pub. Date: Feb. 27, 2014
Zhang, X., Bao, M., Jahres, M. A, Terao K. US Patent. “Subcutaneously Administered Anti-IL-6 Receptor Antibody. Assigned to Hoffmann-La Roche Inc, Genentech Inc. Patent No. 8,580,264 B2. Nov 12, 2013.