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Tozorakimab is a high‐affinity human immunoglobulin G1 monoclonal antibody that neutralizes interleukin (IL)‐33, an IL‐1 family cytokine. This phase 1, single‐center, randomized, double‐blind, placebo‐controlled, single ascending dose study (NCT05070312) evaluated tozorakimab in a healthy Chinese population. Outcomes included the characterization of the pharmacokinetic (PK) profile and immunogenicity of tozorakimab. Safety outcomes included treatment‐emergent adverse events (TEAEs) and clinical laboratory, electrocardiogram, and vital sign parameters. Healthy, non‐smoking, male, and female Chinese participants aged 18‐45 years with a body mass index 19‐24 kg/m2 were enrolled. In total, 36 participants across 2 cohorts of 18 participants were randomized 2:1 to receive a single subcutaneous dose of tozorakimab (300 mg [2 mL] or 600 mg [4 mL]) or matching placebo (2 or 4 mL). Tozorakimab showed dose‐dependent serum PK concentrations with an approximate monophasic distribution in serum over time and a maximum observed peak concentration of 20.1 and 33.7 μg/mL in the 300‐ and 600‐mg cohorts, respectively. No treatment‐emergent anti‐drug antibodies for tozorakimab were observed in any of the participants. There were no clinically relevant trends in the occurrence of TEAEs across the treatment groups. There were no clinically relevant trends over time in clinical laboratory (hematology, clinical chemistry, and urinalysis), electrocardiogram, or vital sign parameters in any treatment group. Overall, tozorakimab demonstrated dose‐dependent systemic exposure in healthy Chinese participants and was well tolerated, with no safety concerns identified in this study. [ABSTRACT FROM AUTHOR]

This article presents data from a phase 1 study on the safety, pharmacokinetics, and efficacy of selumetinib in Chinese pediatric and adult patients with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN). The study found that selumetinib was well-tolerated, with most adverse events being mild. No unexpected trends or serious adverse events were observed, and no patients stopped treatment due to adverse events. The document also provides information on the adverse events experienced by patients receiving selumetinib, as well as the pharmacokinetics of the medication. Additionally, the document summarizes a study on the efficacy and safety of selumetinib in adults with NF1-PN in China. The study found promising efficacy and improvements in quality of life, but caution should be exercised when interpreting the efficacy data as it was a secondary endpoint. The study concluded that selumetinib has an acceptable benefit-risk profile and may address the medical needs of patients with NF1-PN in China. The study was funded by AstraZeneca and Merck Sharp & Dohme LLC. [Extracted from the article]

Respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract infection (LRTI) in infants worldwide. Nirsevimab, an extended half-life monoclonal antibody against RSV, is approved in China for the prevention of RSV lower respiratory tract disease in infants; however, global nirsevimab trials did not enroll Chinese infants. To inform the investigation of nirsevimab for the prevention of RSV LRTI in Chinese infants, this Phase I, randomized, placebo-controlled trial evaluated the pharmacokinetics (PK) and safety of nirsevimab in healthy Chinese adults. Participants were randomized 3:1 to a single 300 mg intramuscular dose of nirsevimab or placebo and were followed through 150 days post-dose. Serum nirsevimab concentrations were measured and PK parameters of maximum serum concentration (C max ), time to maximum concentration (t max ), and area under the concentration-time curve from time 0 to Day 150 (AUC 0-150 ) were estimated. Treatment emergent adverse events (AEs), clinical laboratory data, and vital signs were evaluated. Overall, 24 participants were randomized to nirsevimab (n = 18) or placebo (n = 6). Nirsevimab geometric mean (coefficient of variation [%CV]) C max was 46.9 (21.7) μg/mL, median (range) t max was 7.0 (4.9, 29.9) days, and geometric mean (%CV) AUC 0-150 was 4210.6 (13.6) μg·day/mL. Treatment-emergent AEs (all Grade 1 or Grade 2 in severity) were reported in 5/18 (27.8%) nirsevimab recipients and 2/6 (33.3%) placebo recipients. No serious AEs, new onset chronic disease, or deaths were reported. Overall, safety and PK outcomes were consistent with those observed in healthy adults in the USA, with no new safety concerns., (© 2024 AstraZeneca and The Author(s). Clinical and Translational Science published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)