Comparability of Elezanumab Safety, Tolerability, and Pharmacokinetics in Healthy Japanese, Chinese, and White Participants
HV Kalluri, MR Rosebraugh, N Boehm… - Clinical …, 2024 - Wiley Online Library
Elezanumab is a fully human monoclonal antibody, which is directed against repulsive
guidance molecule A. The safety, tolerability, pharmacokinetics (PK), and immunogenicity of …
guidance molecule A. The safety, tolerability, pharmacokinetics (PK), and immunogenicity of …
[HTML][HTML] Relationship between pharmacokinetics and antidrug antibody Status of ABP 959, a biosimilar candidate to eculizumab: Results from a pharmacokinetic …
V Hanes, J Pan, DT Mytych, D Chien, V Chow - Blood, 2019 - Elsevier
Background: ABP 959 is being developed as a biosimilar to eculizumab, a recombinant
humanized IgG2/4 chimeric monoclonal antibody that binds to the human C5 complement …
humanized IgG2/4 chimeric monoclonal antibody that binds to the human C5 complement …
Phase 1 Evaluation of Elezanumab (anti-RGMa mAb) in Healthy and MS Participants.
HV Kalluri, MR Rosebraugh, TP Misko… - Annals of …, 2022 - europepmc.org
To describe the safety, tolerability, pharmacokinetics, and immunogenicity of elezanumab
(ABT-555), a fully human monoclonal antibody (mAb) directed against Repulsive Guidance …
(ABT-555), a fully human monoclonal antibody (mAb) directed against Repulsive Guidance …
[HTML][HTML] A randomized, double-blind, three-arm, parallel group, single-dose phase I study to evaluate the pharmacokinetic similarity between SB12 (a proposed …
HA Lee, H Jang, D Jeong, Y Kim… - International Journal of …, 2022 - ncbi.nlm.nih.gov
Objectives: To compare the pharmacokinetics (PK), pharmacodynamics (PD), safety, and
immunogenicity between SB12 (a proposed eculizumab biosimilar) and the reference …
immunogenicity between SB12 (a proposed eculizumab biosimilar) and the reference …
[HTML][HTML] Characterization of Anti-Emicizumab Antibodies Using Repository Samples Obtained in Clinical Studies of Emicizumab Conducted in Japan
N Matsumoto, H Abe, R Kawasaki, Y Tashiro… - TH Open, 2023 - thieme-connect.com
Hemophilia A (HA) is a rare bleeding disorder caused by a lack of functional coagulation
factor VIII (FVIII). Treatments for patients with HA (PwHA) can be achieved by administration …
factor VIII (FVIII). Treatments for patients with HA (PwHA) can be achieved by administration …
[HTML][HTML] A randomized, double-blind, single-dose phase 1 comparative pharmacokinetic study comparing SB12 (eculizumab biosimilar) with reference eculizumab in …
HA Lee, H Jang, Y Kim, D Jeong, J Lee, JA Jung… - Blood, 2021 - Elsevier
Background: SB12 has been developed as a biosimilar of the reference product (RP)
eculizumab. Eculizumab is a humanized monoclonal antibody (IgG2/4 kappa …
eculizumab. Eculizumab is a humanized monoclonal antibody (IgG2/4 kappa …
Tolerability, pharmacokinetics and pharmacodynamics of CMAB007, a humanized anti-immunoglobulin E monoclonal antibody, in healthy Chinese subjects
B Zhou, B Lin, J Li, W Qian, S Hou, D Zhang, G Kou… - MAbs, 2012 - Taylor & Francis
The goal of the studies presented here was to determine the tolerability, pharmacokinetic
and pharmacodynamic profiles of CMAB007, a biosimilar of omalizumab (Xolair; a …
and pharmacodynamic profiles of CMAB007, a biosimilar of omalizumab (Xolair; a …
Eculizumab dose tapering should take into account the nonlinearity of its pharmacokinetics
O Le Tilly, P Gatault, S Semlali… - British Journal of …, 2024 - Wiley Online Library
Aims Eculizumab is a monoclonal antibody targeting complement protein C5 used in renal
diseases. As recommended dosing regimen leads to unnecessarily high concentrations in …
diseases. As recommended dosing regimen leads to unnecessarily high concentrations in …
Evaluation of the pharmacokinetics, pharmacodynamics, and safety of a single dose of emicizumab in healthy Chinese subjects
H Li, W Zhang, C Petry, L Li… - Clinical …, 2021 - Wiley Online Library
Abstract This phase 1, open‐label, single‐center study evaluated the pharmacokinetics
(PK), pharmacodynamics, safety, and tolerability of single‐dose emicizumab in healthy …
(PK), pharmacodynamics, safety, and tolerability of single‐dose emicizumab in healthy …
Population pharmacokinetic, pharmacodynamic and efficacy modeling of SB12 (proposed eculizumab biosimilar) and reference eculizumab
H Lee, J Park, H Jang, SJ Lee, J Kim - European Journal of Clinical …, 2024 - Springer
Purpose To describe, compare similarity of pharmacokinetic (PK), pharmacodynamic (PD)
and efficacy of SB12 and reference eculizumab (ECU) and find clinically significant …
and efficacy of SB12 and reference eculizumab (ECU) and find clinically significant …