A Randomized Controlled Dose-Escalation Study of LY06006, a Recombinant Humanized Monoclonal Antibody to RANKL, in Chinese Healthy Adults

Overview

Journal Front Pharmacol

Date 2022 Jul 5

PMID 35784742

Authors

Suping Niu

Min Chen

Diqin Yan

Xiangxing Liu

Shuren Guo

Lun Ou

Huaying Fan

Jie Lv

Qian Wang

Wenliang Dong

Lin Xia

Simin Wang

Gang Liu

Qun Gu

Danjie Guo

Hongxia Liu

Huiying Rao

Qingshan Zheng

Xiaoyan Nie

Haifeng Song

Yi Fang

Affiliations

Soon will be listed here.

Abstract

This study was conducted to explore the safety, tolerance, pharmacokinetics, pharmacodynamics, and immunogenicity of LY06006, a recombinant humanized monoclonal antibody to RANKL, when administrated subcutaneously in Chinese healthy adults. This was a randomized, double-blinded, placebo-controlled, single ascending dose study performed in 32 healthy Chinese adults, who were randomly assigned to receive a single injection dose of 18, 60, 120 mg study drug or placebo with a follow-up of 140-252 days. No deaths or drug-related serious adverse events occurred. LY06006 was rapidly absorbed in the 60 mg group with a T range of 120-480 h and serum LY06006 concentrations decreased slowly 11-13 days after dosing with a long mean (SD) half-life of 389.58 (63.44) h. The most frequent AEs were elevated serum parathyroid hormone (PTH) level (83.3%), hypocalcemia (54.2%), and hypophosphatemia (45.8%). None of the 32 subjects tested positive for anti-drug antibody during the trial. Single-dose subcutaneous administration of LY06006 was safe and well-tolerated in healthy Chinese adults. C showed linear pharmacokinetic characteristics in the dose range of 18-120 mg based on dose-exposure proportionality analysis.

Citing Articles

Phase I, Randomized, Placebo-Controlled, Dose-Escalation Study of GB223, a Fully-Humanized Monoclonal Antibody to RANKL, in Healthy Chinese Adults.

Li C, Liu H, Liao Y, Zhu Y, Tian J, Wang X BioDrugs. 2023; 37(5):721-735.

PMID: 37278972 DOI: 10.1007/s40259-023-00604-7.

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