Safety, tolerability, pharmacokinetics and pharmacodynamics of a single intravenous dose of SHR-1707 in healthy adult subjects: two randomized, double-blind, single-ascending-dose, phase 1 studies

• Published in: Alzheimer's research & therapy Vol. 16; no. 1; pp. 218 - 11
• Main Authors: Yang, Yaru, Qiu, Hongyan, Fan, Yuru, Zhang, Qin, Qin, Huiling, Wu, Juan, Zhang, Xuan, Liu, Yueyue, Zhou, Renpeng, Zhang, Qian, Ye, Zi, Ma, Jingyue, Xu, Ye, Feng, Sheng, Fei, Yue, Li, Na, Cui, Xiaojing, Dong, Fangli, Wang, Quanren, Shen, Kai, Shakib, Sepehr, Williams, Jasmine, Hu, Wei
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 10.10.2024; BioMed Central; BMC
• Subjects: Administration, Intravenous; Adolescent; Adult; Aged; Aged, 80 and over; Alzheimer's disease; Amyloid beta-Peptides; anti-Aβ monoclonal antibody; Antibodies, Monoclonal, Humanized - administration & dosage; Antibodies, Monoclonal, Humanized - pharmacokinetics; Antibodies, Monoclonal, Humanized - pharmacology; Brain research; Care and treatment; Clinical trial; Clinical trials; Dose-Response Relationship, Drug; Double-Blind Method; Drug discovery; Female; Genetic engineering; Healthy Volunteers; Humans; Immunoglobulin G; Male; Methods; Middle Aged; Monoclonal antibodies; Pharmacodynamics; Pharmacokinetics; Safety and security measures; Testing; Young Adult; China; Australia; Clinical trial; anti-Aβ monoclonal antibody; Pharmacodynamics; Alzheimer’s disease; Pharmacokinetics

SHR-1707 is a novel humanized anti-Aβ IgG1 monoclonal antibody that binds to Aβ fibrils and monomers to block the formation of Aβ plaques or to promote the microglial phagocytosis of Aβ. Preclinical studies showed that SHR-1707 reduced brain Aβ deposition in 5xFAD transgenic mice. Herein, we conduct...