Results 251 to 260 of about 337,841 (333)

Pharmacokinetics, Safety, and Tolerability of Single‐Dose Dazukibart in Healthy Adults in China and Japan: Results From 2 Randomized, Double‐Blind, Phase 1 Studies

open access: yesClinical Pharmacology in Drug Development, EarlyView.
Abstract Dazukibart is a humanized monoclonal antibody selectively targeting interferon‐β. The pharmacokinetics (PK), safety, tolerability, and immunogenicity of dazukibart were evaluated in 2 double‐blind, randomized, placebo‐controlled, single‐dose, Phase 1 studies in healthy adults in China (Study 1: N = 18; dazukibart 900 mg = 15; placebo = 3) and ...
Naihan Chen   +10 more
wiley   +1 more source

Safety, Tolerability, and Pharmacokinetics of Donanemab in Healthy Chinese Participants: A Phase 1, Randomized, Double‐Blind, Placebo‐Controlled Study

open access: yesClinical Pharmacology in Drug Development, EarlyView.
Abstract Alzheimer's disease (AD), characterized by β‐amyloid (Aβ) plaques and neurofibrillary tangles, is the leading cause of dementia globally. Donanemab is a humanized immunoglobulin G1 in development as a treatment to slow AD progression. This study aimed to evaluate the safety, tolerability, pharmacokinetics (PKs), and immunogenicity of donanemab
Junyu Xu   +5 more
wiley   +1 more source

Effect of Mild to Moderate Hepatic Impairment on Valemetostat Pharmacokinetics: An Open‐Label, Phase I Study

open access: yesClinical Pharmacology in Drug Development, EarlyView.
Abstract Valemetostat tosylate (valemetostat) is a dual inhibitor of enhancer of zeste homolog (EZH) 2 and EZH1, approved in Japan for the treatment of relapsed/refractory peripheral T‐cell lymphoma and adult T‐cell leukemia/lymphoma. This Phase I, open‐label study evaluated the pharmacokinetics and safety of a single 50‐mg oral dose of valemetostat in
Masaya Tachibana   +8 more
wiley   +1 more source

A Randomized Thorough QT Trial Using Concentration‐QT Analysis to Evaluate the Effects of Centanafadine on Cardiac Repolarization

open access: yesClinical Pharmacology in Drug Development, EarlyView.
Abstract Centanafadine is a norepinephrine/dopamine/serotonin reuptake inhibitor in development for treatment of attention‐deficit/hyperactivity disorder. This double‐blind, placebo‐ and moxifloxacin‐controlled, 3‐period crossover trial evaluated the effects of centanafadine (EB‐1020) and its metabolite (EB‐10601) on cardiac repolarization in 30 ...
Osman S. Turkoglu   +3 more
wiley   +1 more source

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