Ignatenko, S., Skrumsager, B. K. & Mouritzen, U. Safety, PK, and PD of recombinant anti-interleukin-21 monoclonal antibody in a first-in-human trial.
To evaluate safety and feasibility in a first-in-human trial of a direct magnetic resonance imaging (MRI -guided prostate biopsy using a novel robotic device.
A novel amyloid β (Aβ) synthetic peptide vaccine (UB-311) has been evaluated in a first-in-human trial with patients of mild-to-moderate Alzheimer's disease.
Sen M, Thomas SM, Kim S, Yeh JI, Ferris RL, Johnson JT, et al. First-in-human trial of a STAT3 decoy oligonucleotide in head and neck tumors: implications for cancer therapy.
(A second drug, rituximab, was approved by US regulators in August for people with Waldenström's, but it must be used in combination with ibrutinib). In addition, there was a newly launched first-in-human trial of zanubrutinib, a more potent and potentially safer BTK inhibitor.
The group at UC Davis has completed the first phase of their project plan, "Pre-Cell", and are working to prove that delivery of MSCs can be done safely in larger mammals in order to receive approval for the first in-human trial of gene therapy engineered MSCs implanted into the brains of patients with Huntington's disease.
Based on these discussions, a group of experts convened to discuss how to improve the confidence in QT data from early clinical studies, for example, the First-Time-in-Human trial, through collection of serial electrocardiograms and pharmacokinetic samples and the use of exposure response analysis.
The objective of this first-in-human trial included the safety, maximum tolerated dose (MTD), pharmacokinetics, immunogenicity and antitumour effects of KRN330, a novel fully-human monoclonal antibody directed against A33, a membrane bound glycoprotein uniformly expressed in 95% of colorectal cancers.
