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Safety, efficacy, and immunogenicity of a novel IgG degrading enzyme (KJ103): results from two randomised, blinded, phase 1 clinical trials.
Gene Ther
January 2025
Shanghai Bao Pharmaceuticals Co., Ltd., No. 28 Luoxin Road, Baoshan, Shanghai, China.
The approved intravenous adeno-associated virus (AAV) therapies are limited by the widespread prevalence of pre-existing anti-AAV antibodies in the general population, which are known to restrict patients' ability to receive gene therapy and limit transfection efficacy in vivo. To address this challenge, we have developed a novel recombinant human immunoglobulin G degrading enzyme KJ103, characterized by low immunogenicity and clinical value for the elimination of anti-AAV antibodies in gene transfer. Herein, we conducted two randomized, blinded, placebo-controlled, single ascending dose Phase I studies in China and New Zealand, to evaluate the pharmacokinetics, pharmacodynamics, safety and immunogenicity of KJ103 in healthy volunteers.
View Article and Find Full Text PDFPrepartum supplementation of Ascophyllum nodosum meal or ethylenediamine dihydroiodide: Effects on colostrum yield and growth and health of dairy calves.
J Dairy Sci
January 2025
Department of Agriculture, Nutrition, and Food Systems, University of New Hampshire, Durham, NH 03824. Electronic address:
We aimed to evaluate the effects of prepartum supplementation of different I sources (Ascophyllum nodosum [ASCO] meal and ethylenediamine dihydroiodide [EDDI]) on colostrum yield of cows, and blood concentrations of glucose, BHB, and thyroid hormones and growth of dairy calves. Forty multiparous Holstein cows were blocked by lactation number and expected calving date and assigned to 1 of 4 treatments 28 d before parturition: (1) EDDI supplemented (11 mg/d) to a basal diet to meet the NRC (2001) I concentration of 0.5 mg of I/kg of DMI (control = CON [0 g/d of ASCO meal]; actual I concentration = 0.
View Article and Find Full Text PDFEffects of low phosphorus diets on phosphorus balance and plasma concentrations of 25-hydroxyvitamin D3, and carboxy-terminal collagen crosslinks during the transition period in dairy cows.
J Dairy Sci
January 2025
Department of Population Health Sciences, Faculty of Veterinary Medicine, Utrecht University, Yalelaan 7, 3584 CL Utrecht, the Netherlands.
Our aim was to determine the effects of P intake on P balance, serum parathyroid hormone (PTH) levels and bone resorption during the final 4 weeks prepartum and the first 8 weeks of lactation. Sixty pregnant multiparous Holstein Friesian dairy cows were assigned to a randomized block design with repeated measurements and dietary treatments arranged according to a 2 × 2 factorial design. The experimental diets contained 3.
View Article and Find Full Text PDFAdenosine accumulation in the blood of newborn mice weakens antimicrobial host defenses.
J Leukoc Biol
January 2025
Department of Surgery, University of California, San Diego Health, San Diego, CA, USA.
Pediatric intensive care patients are particularly susceptible to severe bacterial infections because of ineffective neutrophil responses. The reasons why neutrophils of newborns are less responsive than those of adults are not clear. Because adenosine triphosphate (ATP) and adenosine (ADO) tightly regulate neutrophils, we studied whether the ATP and ADO levels in the blood of newborn mice could impair the function of their neutrophils.
View Article and Find Full Text PDFDevelopment and validation of a UPLC-MS/MS method for simultaneous quantification of polymyxins and caspofungin in human plasma for therapeutic drug monitoring.
J Chromatogr B Analyt Technol Biomed Life Sci
January 2025
School of Pharmacy, Lanzhou University, Lanzhou 730030 China; Department of Pharmacy, The Second Hospital & Clinical Medical School, Lanzhou University, Lanzhou 730030 China. Electronic address:
Objective: To develop a rapid, convenient, accurate, and low-residual-effect ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method for the determination of polymyxin B sulfate and colistin sulfate in the blood of patients with multidrug-resistant bacterial infections, as well as caspofungin acetate in the blood of patients with fungal infections, thus facilitating the rational use of antibiotics in clinical applications.
Methods: All analytes were diluted with 0.2 % aqueous formic acid, and plasma proteins were precipitated using acetonitrile.
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