Publications by authors named "Cecil Chi-Keung Chen"
Introduction: The aim of this study was to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD7442 (tixagevimab/cilgavimab) in healthy Japanese adults.
Methods: In this randomized, double-blind, placebo-controlled, phase 1 study, AZD7442 was administered intramuscularly (300 or 600 mg) or intravenously (300 or 1000 mg) to healthy Japanese adults. Primary endpoints were safety, tolerability, and pharmacokinetics.
Purpose: Biological therapies targeting eosinophils have been shown to be effective in treating patients with severe eosinophilic asthma. Benralizumab (Fasenra, AstraZeneca) is a humanized monoclonal antibody binding to the alpha subunit of the interleukin-5 receptor, which rapidly depletes eosinophils via antibody-dependent cellular cytotoxicity. The aim of this Phase 1 study was to assess the safety, tolerability, and pharmacokinetics of benralizumab in healthy Chinese individuals.
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- Tremelimumab is a monoclonal antibody studied for cancer treatment, both alone and with durvalumab, and this study analyzes its pharmacokinetics and how patient factors affect it.
- Researchers created a population pharmacokinetics model using data from 5 studies with 956 patients and validated it with an additional 4 studies involving 554 patients.
- The findings show that tremelimumab has linear pharmacokinetics, with varying clearance rates based on treatment type, but recommendations for dosage adjustments aren't necessary despite differences in patient bodyweight and albumin levels.
The cut point is an important parameter for immunogenicity assay validation and critical to immunogenicity assessment in clinical trials. FDA (2019) recommends using a statistical approach to derive cut point, with an appropriate outlier removal procedure. In general, the industry follows the methods described in Shankar et al.
View Article and Find Full Text PDFPurpose: Patients with advanced urothelial carcinoma who fail platinum-containing chemotherapy (treatment fails) have a poor prognosis and limited treatment options. Recent approvals of immune-checkpoint inhibitors confirmed the value of immunomodulatory therapy in urothelial carcinoma. Tremelimumab is a selective human immunoglobulin G2 (IgG2) monoclonal antibody against cytotoxic T-lymphocyte-associated antigen 4 with demonstrated durable response rate in metastatic melanoma.
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