Publications

  • Yamashita, T., 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.
  • Judge, D. P., 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. doi: 0.1007/s10557-019-06919-4.
  • 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.
  • 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.
  • Zhang, X., Sweetser, M. Results from APOLLO phase 3 study of patisiran, the first approved RNAi therapeutic, in hereditary ATTR (hATTR) amyloidosis patients with polyneuropathy. Clin Pharmacol Ther. 2019;105(S1);E-009;S31.
  • Zhang, X., Goel, V., Robbie, G. Pharmacokinetics of patisiran in patients with hereditary transthyretin-mediated amyloidosis. J Neuromuscul Dis. 2018;5:S280; Abstract 568.
  • Zhang, X., Brennan, B. Disease-drug-drug interaction assessments for tocilizumab – a monoclonal antibody against interleukin-6 receptor to treat patients with rheumatoid arthritis. In: Drug-Drug Interaction for Therapeutic Proteins (H. Zhou and B. Meibohm, eds.), ISBN 978-1-118-03216-9. WILEY Wiley-Blackwell Publisher. 2013.
  • Goel, V., Zhang, X., et al. Population pharmacokinetics (PK) of patisiran in healthy volunteers and in patients. J Neuromuscul Dis. 2018;5:S251.Abstract 567.
  • Zhang, X., et al. Patisiran-LNP pharmacokinetics (PK), pharmacodynamics (PD), and exposure-response (E-R) relationship in patients with hereditary transthyretin-mediated (hATTR) amyloidosis with polyneuropathy. Eur J Neurol. 2018;25 (Suppl. 2); Abstract EPR2142; 460.
  • Goel, V., Zhang, X., et al. Population pharmacokinetic (PK)/pharmacodynamic (PD) model of serum transthyretin (TTR) following patisiran-LNP administration in healthy volunteers and patients with hereditary TTR-mediated (hATTR) amyloidosis with polyneuropathy. Eur J Neurol. 2018;25 (Suppl. 2); Abstract EPR1139; 354.
  • Zhang, X., Goel, V., Robbie, G. Pharmacokinetics of patisiran in patients with hereditary transthyretin-mediated amyloidosis. J Neuromuscul Dis. 2018;5, S280. Abstract 568.
  • Mahadevan, D., 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.
  • Mukai, M., 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): 93-201.
  • Zhang, X., Imel, E. A., et al. Population pharmacokinetic and pharmacodynamic analyses from a 4-Month intra-dose 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(2):176-185.
  • Ruppe, M. D., Zhang, X., 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.
  • 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.
  • Whitley, C. B., Zhang, X. Results of the phase 1/2, open-label clinical study of intravenous recombinant human N-acetyl-α-D-Glucosaminidase (SBC-103) in children with mucopolysaccharidosis IIIB. Mol Genet Metab. 2019;126(2);131-138.
  • Zhang, X., Chen, Y-C,, and Terao, K. Clinical pharmacology of tocilizumab for the treatment of polyarticular-course juvenile idiopathic arthritis. Expert Rev Clin Pharmacol. 2017;10(5):471-482.
  • Zhang, X., Peyret, T., et al. Population pharmacokinetic and pharmacodynamic analyses from a 4-month intra-dose 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):429-38.
  • Sarantopoulos, J., 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(3):317-27.
  • Duvic, M., 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.
  • Imel, E. A., Zhang, X., 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):2565-73.
  • 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.
  • 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.
  • Carpenter, T. O., Zhang, X., et al. A First-In-Human, randomized, double-blind, placebo-controlled, single-dose study of a human monoclonal anti-FGF23 antibody (KRN23) in X-linked hypophosphatemia. J Bone Miner Res. 2013;28 (Suppl 1)
  • Zhang, X., Carpenter, T.O., et al. Pharmacokinetics and pharmacodynamics of a human monoclonal anti-FGF23 antibody (KRN23) after single-dose administration to patients with X-linked hypophosphatemia. J Bone Miner Res. 2013;28 (Suppl 1).
  • Zhang, X., Chen, Y-C., et al. Clinical study to investigate pharmacokinetics, pharmacodynamics, efficacy, and safety of tocilizumab after subcutaneous administration weekly or every 2 weeks in patients with rheumatoid arthritis. Int J Clin Pharmacol Ther. 2013;51(8); 620-630.
  • Zhang, X., Georgy, A., Rowell, L. An Open-label, single-center study investigating 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
  • Morcos, P., Zhang, X. 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.
  • Zhang, X., Hsu, J., et al. Pharmacokinetics (PK) and pharmacodynamics (PD) of tocilizumab (TCZ) in polyarticular course juvenile idiopathic arthritis (pcJIA). Clin Pharmacol Ther. 2013;93 (Suppl 1): S88 (PIII-60).
  • Zhang, X., Morcos, P., Terao, K. Clinical Pharmacology of Tocilizumab for the Treatment of Patients With Systemic Juvenile Idiopathic Arthritis. Expert Rev Clin Pharmacol. 2013;6(2), 123–137
  • Zhang, X., Chen, Y-C., et al. A Clinical study to investigate pharmacokinetics, pharmacodynamics, efficacy, and safety of tocilizumab after subcutaneous administration weekly or every two weeks in patients with rheumatoid arthritis. Clin Pharmacol Ther. 2012;91 (Suppl 1): S117 (PIII-60).
  • Zhang, X., Chen, Y-C., et al. A Clinical study to investigate pharmacokinetics, pharmacodynamics, efficacy, and safety of tocilizumab after subcutaneous administration weekly or every two weeks in patients with rheumatoid arthritis. Clin Pharmacol Ther. 2012; 91 (Suppl 1): S117 (PIII-60).
  • 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.
  • Zhang, X., et al: Pharmacokinetics (PK) and pharmacodynamics (PD) of tocilizumab in patients with systemic juvenile rheumatoid arthritis: 12-week data from the phase 3 Tender trial. Ann Rheum Dis. 2010;69 (Suppl 3):641
  • Zhang X., et al: Pharmacokinetics and pharmacodynamics of tocilizumab in systemic juvenile idiopathic arthritis. Ann Rheum Dis. 2010;70 (Suppl 3):409.
  • Schmitt, C., Kuhn, B., Zhang, X., Kivitz, A., Grange, S. Tocilizumab has no clinically relevant effects on methotrexate pharmacokinetics in patients with rheumatoid arthritis. Int J Clin Pharmacol Ther. 2011;30(3):218-223
  • Zhang, X., Schmitt, C., et al. Disease-drug interaction studies of tocilizumab with cytochrome P450 substrates in vitro and in vivo. Clin Pharmacol Ther. 2009;85 (supplement 1):S59.
  • Schmitt, C., Kuhn, B., Zhang, X., Kivitz, A. J., Grange, S. Disease-drug-drug interaction involving tocilizumab and simvastatin in patients with rheumatoid arthritis. Clin Pharmacol Ther. 2011;89(5):735-740.
  • Grange, S., Schmitt, C., Banken, L,, Kuhn, B., 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):648-55.
  • Zhang, X., et al. Pharmacokinetics and pharmacodynamics of tocilizumab in systemic juvenile idiopathic arthritis. Clin Pharmacol Ther. 2011;89, S36–S37.
  • Zhang, X., Jordan, P., et al. Thorough QT/QTc study of ritonavir-boosted saquinavir following multiple-dose administration of therapeutic and supratherapeutic doses in healthy participants. J Clin Pharmacol. 2012;52(4):520-529.
  • Zhang, X., Fettner, S., et al. Pharmacokinetic interaction study of ritonavir-boosted saquinavir in combination with rifabutin in healthy subjects. Antimicrob Agents Chemother. 2011;55(2):680–687.
  • Zhang, X., Fettner, S., et al. Metabolism and excretion of a novel p38 MAP kinase inhibitor pamapimod in healthy male subjects. I J Clin Pharmacol Ther, 2011;49(6): 345-352.
  • Zhang, X., Huang, Y., 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. Clin Pharmacol. 2010;50(9):1031-8.
  • Zhang, X., Silkey, M., Schumacher, M., Wang, L., Raval, H., Caulfield, J. P. 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):534-9.
  • Jamois, C., Zhang, X., et al. 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.
  • Kaeser, K., Zhang, X., et al. Drug-drug interaction study of ketoconazole and ritonavir-boosted saquinavir. Antimicrob Agents Chemother. 2009;53(2):609–614.
  • 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):510-7.
  • Patel, I. H., Zhang, X., Nieforth, K., Salgo, M., Buss, N. Pharmacokinetics, pharmacodynamics and drug Interaction potential of enfuvirtide. Clin Pharmacokinet. 2005;44(2):175-86.
  • Mould, D. R., Zhang, X., Nieforth, K., 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):515-28.
  • Ruxrungtham, K., 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.
  • 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):558-68.
  • 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):1382-91.
  • 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.
  • 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.

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.