A Phase 1 Study of KHK4083: A Single‐Blind, Randomized, Placebo‐Controlled Single‐Ascending‐Dose Study in Healthy Adults and an Open‐Label Multiple‐Dose Study in Patients With Ulcerative Colitis
Sign Up to like & getrecommendations! Published in 2021 at "Clinical Pharmacology in Drug Development"
DOI: 10.1002/cpdd.918
Abstract: OX40 plays an essential role in maintaining late T‐cell proliferation and survival by suppressing apoptosis and by inducing T‐cell memory formation. Here, we report the results of the phase 1 study of KHK4083, a fully… read more here.
Keywords: study khk4083; study; ulcerative colitis; dose ... See more keywords
Pharmacokinetics and Pharmacodynamics of Itepekimab in Healthy Adults and Patients With Asthma: Phase I First-in-Human and First-in-Patient Trials.
Sign Up to like & getrecommendations! Published in 2021 at "Clinical and translational science"
DOI: 10.1111/cts.13157
Abstract: Itepekimab is a monoclonal antibody that targets interleukin-33 and has been shown to reduce airway inflammation and associated tissue damage in preclinical studies. We assessed the safety, tolerability, pharmacokinetics, and pharmacodynamic profiles of single-ascending and… read more here.
Keywords: healthy adults; pharmacokinetics pharmacodynamics; itepekimab; patients asthma ... See more keywords
A phase I, randomized, single-dose study evaluating the pharmacokinetic equivalence of TAB008 and bevacizumab in healthy volunteers.
Sign Up to like & getrecommendations! Published in 2018 at "Journal of Clinical Oncology"
DOI: 10.1200/jco.2018.36.15_suppl.e14504
Abstract: e14504Background: This study compared the pharmacokinetic (PK) profiles of the biosimilar TAB008 with bevacizumab (EU) in healthy adult males. Methods: A randomized, double-blind, single-dose study... read more here.
Keywords: bevacizumab healthy; study; tab008 bevacizumab; single dose ... See more keywords
Safety, tolerance, and pharmacokinetics of salvianolic acid B in healthy Chinese volunteers: A randomized, double-blind, placebo-controlled phase 1 clinical trial
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DOI: 10.3389/fphar.2023.1146309
Abstract: Background: Salvianolic acid B (Sal B) is one of the main active ingredients of Salvia miltiorrhiza Bunge. In China, many traditional Chinese medicines have been modified into injections for higher bioavailability and better efficacy. Salvianolic… read more here.
Keywords: safety; dose study; ascending dose; salvianolic acid ... See more keywords