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Items: 1 to 20 of 223

1.

Pharmacokinetics, pharmacodynamics and safety of a human anti-IL-6 monoclonal antibody (sirukumab) in healthy subjects in a first-in-human study.

Xu Z, Bouman-Thio E, Comisar C, Frederick B, Van Hartingsveldt B, Marini JC, Davis HM, Zhou H.

Br J Clin Pharmacol. 2011 Aug;72(2):270-81. doi: 10.1111/j.1365-2125.2011.03964.x.

2.

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

Zhuang Y, Xu Z, de Vries DE, Wang Q, Shishido A, Comisar C, Ford JA, Keen M, Achira M, Tsukamoto Y, Petty KJ, Davis HM, Zhou H.

Int J Clin Pharmacol Ther. 2013 Mar;51(3):187-99. doi: 10.5414/CP201785.

PMID:
23357841
3.

Safety, tolerability and pharmacokinetics of a human anti-interleukin-13 monoclonal antibody (CNTO 5825) in an ascending single-dose first-in-human study.

van Hartingsveldt B, Nnane IP, Bouman-Thio E, Loza MJ, Piantone A, Davis HM, Petty KJ.

Br J Clin Pharmacol. 2013 May;75(5):1289-98. doi: 10.1111/j.1365-2125.2012.04477.x.

4.

Phase I, randomized, double-blind, placebo-controlled, multiple intravenous, dose-ascending study of sirukumab in cutaneous or systemic lupus erythematosus.

Szepietowski JC, Nilganuwong S, Wozniacka A, Kuhn A, Nyberg F, van Vollenhoven RF, Bengtsson AA, Reich A, de Vries DE, van Hartingsveldt B, Robinson DW Jr, Gordon R, Hsu B.

Arthritis Rheum. 2013 Oct;65(10):2661-71. doi: 10.1002/art.38091.

5.

First-in-human study to assess guselkumab (anti-IL-23 mAb) pharmacokinetics/safety in healthy subjects and patients with moderate-to-severe psoriasis.

Zhuang Y, Calderon C, Marciniak SJ Jr, Bouman-Thio E, Szapary P, Yang TY, Schantz A, Davis HM, Zhou H, Xu Z.

Eur J Clin Pharmacol. 2016 Nov;72(11):1303-1310. Epub 2016 Aug 11.

PMID:
27515978
6.

Pharmacokinetics and safety of golimumab, a fully human anti-TNF-alpha monoclonal antibody, in subjects with rheumatoid arthritis.

Zhou H, Jang H, Fleischmann RM, Bouman-Thio E, Xu Z, Marini JC, Pendley C, Jiao Q, Shankar G, Marciniak SJ, Cohen SB, Rahman MU, Baker D, Mascelli MA, Davis HM, Everitt DE.

J Clin Pharmacol. 2007 Mar;47(3):383-96.

PMID:
17322150
7.

Efficacy, pharmacokinetic, and safety assessment of adalimumab, a fully human anti-tumor necrosis factor-alpha monoclonal antibody, in adults with rheumatoid arthritis receiving concomitant methotrexate: a pilot study.

Weisman MH, Moreland LW, Furst DE, Weinblatt ME, Keystone EC, Paulus HE, Teoh LS, Velagapudi RB, Noertersheuser PA, Granneman GR, Fischkoff SA, Chartash EK.

Clin Ther. 2003 Jun;25(6):1700-21.

PMID:
12860493
8.

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.

Zhuang Y, de Vries DE, Xu Z, Marciniak SJ Jr, Chen D, Leon F, Davis HM, Zhou H.

J Clin Pharmacol. 2015 Dec;55(12):1386-94. doi: 10.1002/jcph.561. Epub 2015 Jul 29.

PMID:
26054042
9.

Safety and clinical pharmacokinetics of nemonoxacin, a novel non-fluorinated quinolone, in healthy Chinese volunteers following single and multiple oral doses.

Guo B, Wu X, Zhang Y, Shi Y, Yu J, Cao G, Zhang J.

Clin Drug Investig. 2012 Jul 1;32(7):475-86. doi: 10.2165/11632780-000000000-00000.

PMID:
22650326
10.

Pharmacokinetic and pharmacodynamic characteristics of single-dose Canakinumab in patients with type 2 diabetes mellitus.

Noe A, Howard C, Thuren T, Taylor A, Skerjanec A.

Clin Ther. 2014 Nov 1;36(11):1625-37. doi: 10.1016/j.clinthera.2014.08.004. Epub 2014 Sep 18.

11.

Anti-IL21 receptor monoclonal antibody (ATR-107): Safety, pharmacokinetics, and pharmacodynamic evaluation in healthy volunteers: a phase I, first-in-human study.

Hua F, Comer GM, Stockert L, Jin B, Nowak J, Pleasic-Williams S, Wunderlich D, Cheng J, Beebe JS.

J Clin Pharmacol. 2014 Jan;54(1):14-22. doi: 10.1002/jcph.158. Epub 2013 Sep 17.

PMID:
23913720
12.

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

Nnane IP, Xu Z, Zhou H, Davis HM.

Basic Clin Pharmacol Toxicol. 2015 Oct;117(4):219-25. doi: 10.1111/bcpt.12391. Epub 2015 Mar 5.

13.

Tolerability and pharmacokinetics of TB-402 in healthy male volunteers.

Verhamme P, Pakola S, Jensen TJ, Berggren K, Sonesson E, Saint-Remy JM, Balchen T, Belmans A, Cahillane G, Stassen JM, Peerlinck K, Glazer S, Jacquemin M.

Clin Ther. 2010 Jun;32(6):1205-20. doi: 10.1016/j.clinthera.2010.06.012.

PMID:
20637972
14.

Vedolizumab Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability Following Administration of a Single, Ascending, Intravenous Dose to Healthy Volunteers.

Rosario M, Wyant T, Leach T, Sankoh S, Scholz C, Parikh A, Fox I, Feagan BG.

Clin Drug Investig. 2016 Nov;36(11):913-923.

PMID:
27422740
15.

Population pharmacokinetics of sifalimumab, an investigational anti-interferon-α monoclonal antibody, in systemic lupus erythematosus.

Narwal R, Roskos LK, Robbie GJ.

Clin Pharmacokinet. 2013 Nov;52(11):1017-27. doi: 10.1007/s40262-013-0085-2.

16.

Pharmacokinetics and safety of single and multiple doses of ACHN-490 injection administered intravenously in healthy subjects.

Cass RT, Brooks CD, Havrilla NA, Tack KJ, Borin MT, Young D, Bruss JB.

Antimicrob Agents Chemother. 2011 Dec;55(12):5874-80. doi: 10.1128/AAC.00624-11. Epub 2011 Sep 12.

17.

Pharmacokinetics and safety of golimumab in healthy Chinese subjects following a single subcutaneous administration in a randomized phase I trial.

Zhuang Y, Lyn S, Lv Y, Xu Z, Bouman-Thio E, Masterson T, Ford JA, Keen M, Petty KJ, Davis HM, Zhou H.

Clin Drug Investig. 2013 Nov;33(11):795-800. doi: 10.1007/s40261-013-0124-7.

PMID:
23975656
18.

Two first-in-human, open-label, phase I dose-escalation safety trials of MEDI-528, a monoclonal antibody against interleukin-9, in healthy adult volunteers.

White B, Leon F, White W, Robbie G.

Clin Ther. 2009 Apr;31(4):728-40. doi: 10.1016/j.clinthera.2009.04.019.

PMID:
19446146
19.

First human study of a chimeric anti-methamphetamine monoclonal antibody in healthy volunteers.

Stevens MW, Henry RL, Owens SM, Schutz R, Gentry WB.

MAbs. 2014;6(6):1649-56. doi: 10.4161/19420862.2014.976431.

20.

Pharmacokinetics, safety and tolerability of intravenous ferric carboxymaltose: a dose-escalation study in volunteers with mild iron-deficiency anaemia.

Geisser P, Banké-Bochita J.

Arzneimittelforschung. 2010;60(6a):362-72. doi: 10.1055/s-0031-1296301.

PMID:
20648928

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