Safety and Pharmacokinetics of Long-Acting Monoclonal Antibodies Tixagevimab and Cilgavimab (AZD7442) in a China Phase 2 Study and Evaluation of Asian Race Effect.

Safety, pharmacokinetics, and impact of race of pharmacokinetics on monoclonal antibodies tixagevimab and cilgavimab (AZD7442) were assessed in Chinese adult participants in a Phase 2, randomized, double-blind, placebo-controlled trial. In total, 272 participants were randomized 3:1 to a single intravenous dose of 600 mg AZD7442 or placebo and followed for 451 days. Mean participant age was 34.

Safety, Tolerability, and Pharmacokinetics of the Long-Acting SARS-CoV-2-Neutralizing Monoclonal Antibody Combination AZD7442 (Tixagevimab/Cilgavimab) in Healthy Chinese Adults.

AZD7442, a combination of extended half-life monoclonal antibodies tixagevimab and cilgavimab, was shown to neutralize previously circulating SARS-CoV-2 variants. This study evaluated safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD7442 in healthy Chinese adults. In this randomized, placebo-controlled, Phase 1 study, AZD7442 was administered intramuscularly or intravenously (300 or 600 mg).

A phase I, randomized, placebo-controlled trial to evaluate the pharmacokinetics, safety, and tolerability of nirsevimab in healthy Chinese adults.

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.

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Tolerability After Subcutaneous Administration of Tozorakimab in Healthy Chinese Participants.

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, Tolerability, and Pharmacokinetics of Benralizumab: A Phase 1, Randomized, Single-Blind Study of Healthy Chinese Participants.

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.

Reduced mother-to-child transmission of hepatitis B after implementation of completely charge-free active-passive immunoprophylaxis: an observational cohort study.

: China has implemented universal hepatitis B vaccination since 2002 and provided charge-free hepatitis B immunoglobulin (HBIG) to infants of HBV-infected mothers since July 2011. We aimed to compare mother-to-child transmission (MTCT) in children born before and since July 2011.: In total, 5,149 children of HBV-infected mothers were tested for HBV markers.

Prevention of Mother-to-Child Transmission of HIV: Data Analysis Based on Pregnant Women Population from 2012 to 2018, in Nantong City, China.

Background: China has implemented a nation-wide policy to control mother-to-child transmission (MTCT) of the human immunodeficiency virus (HIV) since 2011, yet the efficacy of the control policy is less studied. The aim of the present study was to report the data in the prevention of MTCT of HIV in Nantong city, China.

Methods: The screening and prevalence of HIV in pregnant women and the efficacy of prophylaxis in Nantong city, China, January 2012 through December 2018, were analyzed.

Dorzagliatin monotherapy in Chinese patients with type 2 diabetes: a dose-ranging, randomised, double-blind, placebo-controlled, phase 2 study.

Background: Glucokinase acts as a glucose sensor in the pancreas and a glucose processor in the liver, and has a central role in glucose homoeostasis. Dorzagliatin is a new, dual-acting, allosteric glucokinase activator that targets both pancreatic and hepatic glucokinases. Dorzagliatin has good pharmacokinetic and pharmacodynamic properties in humans, and provides effective 24-h glycaemic control and improves glucose sensitivity in patients with type 2 diabetes.