[Translation] A randomized, double-blind, placebo-controlled, single-dose escalation phase I study to evaluate the safety, tolerability, PK and PD of GB223 in healthy adult subjects

评价在健康受试者中GB223单次给药的安全性及耐受性；评价在健康受试者中GB223单次给药的药代动力学特征；评价在健康受试者中GB223单次给药的免疫原性；评价在健康受试者中GB223单次给药的药效学特点；

[Translation]

To evaluate the safety and tolerability of a single dose of GB223 in healthy subjects; To evaluate the pharmacokinetic characteristics of a single dose of GB223 in healthy subjects; To evaluate the immunogenicity of a single dose of GB223 in healthy subjects; To evaluate the pharmacodynamic characteristics of a single dose of GB223 in healthy subjects;

Start Date16 Nov 2018

Sponsor / Collaborator

Genor Biopharma Co., Ltd.

NCT04178044 / Unknown statusPhase 1

A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalated Phase Ⅰ Study to Evaluate the Safety, Tolerability, Pharmacokinetic(PK) and Pharmacodynamic(PD) of GB223 in Healthy Adult Subjects.

The primary objective of this study is to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of single dose of GB223 in healthy subjects; the secondary objective is to evaluate the immunogenicity and pharmacodynamic (PD) profiles of single dose of GB223 in healthy subjects.

Start Date16 Nov 2018

Sponsor / Collaborator

Genor Biopharma Co., Ltd.

ChiCTR1800020338 / RecruitingPhase 1IIT

A randomized, double-blind, placebo-controlled, Phase I trial for evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of GB223 in Chinese healthy adult subjects

Start Date19 Oct 2018

Sponsor / Collaborator-

100 Clinical Results associated with GB-223

100 Translational Medicine associated with GB-223

100 Patents (Medical) associated with GB-223

Literatures (Medical) associated with GB-223

01 Sep 2023·BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy

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

Article

Author: Li, Yongmei ; Hu, Zhiqin ; Fang, Yi ; Li, Xianbo ; Li, Chen ; Liao, Yixiang ; He, Jin ; Shang, Dewei ; Liang, Xintong ; Wang, Tenghua ; Tian, Jingyuan ; Zhu, Yu ; Song, Haifeng ; Zhan, Yaoxuan ; Liu, Haiyan ; Zheng, Qingshan ; Wang, Xuan

BACKGROUNDGB223 is a novel, fully-humanized monoclonal antibody against the receptor activator of nuclear factor-kappa B ligand (RANKL). In this phase I study, the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of GB223 were investigated.PATIENTS AND METHODSThis was a randomized, double-blinded, placebo-controlled, single-dose escalation study conducted in 44 healthy Chinese adults. Participants were randomly assigned to receive a single subcutaneous injection dose of 7, 21, 63, 119, or 140 mg of GB223 (n = 34) or placebo (n = 10) and were followed up for 140-252 days.RESULTSThe results of noncompartmental analysis showed that GB223 was slowly absorbed after dosing, with a time to reach maximum concentration (T_max) ranging from 5 to 11 days. Serum GB223 concentrations decreased slowly, with a long half-life ranging from 7.91 to 19.60 days. A two-compartment Michaelis-Menten model was found to best describe the pharmacokinetics of GB223, and the absorption rate of GB223 differed between males (0.0146 h^-1) and females (0.0081 h^-1). Serum C-terminal telopeptide of type I collagen decreased significantly postdose, and the inhibition lasted 42-168 days. No deaths or drug-related serious adverse events occurred. The most frequent adverse events were blood parathyroid hormone increased (94.1%), blood phosphorus decreased (67.6%) and blood calcium decreased (58.8%). In the GB223 group, 44.1% (15/34) of subjects were antidrug antibody positive after dosing.CONCLUSIONIn this study, we demonstrated for the first time that a single subcutaneous injection of GB223, from 7 to 140 mg, is safe and well tolerated in healthy Chinese subjects. GB223 has a nonlinear pharmacokinetic profile, and sex was a potential covariate that may affect the absorption rate of GB223.CLINICAL TRIAL REGISTRATIONNCT04178044 and ChiCTR1800020338.

100 Deals associated with GB-223

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Giant Cell Tumor of Bone	Phase 1	CN	Genor Biopharma Co., Ltd.	17 Jan 2019
Osteoporosis, Postmenopausal	Phase 1	CN	Genor Biopharma Co., Ltd.	16 Nov 2018
Bone Cancer	Preclinical	CN	Genor Biopharma Co., Ltd.	16 Nov 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04178044 (Pubmed)	Phase 1	-	44	GB223	jkrwsxlozv(zuzusdslac) = rdqlsvxbef hpnnxyqfjx (vdmrjouaos ) View more	-	06 Jun 2023
				Placebo	jkrwsxlozv(zuzusdslac) = ltsczuvqpx hpnnxyqfjx (vdmrjouaos )

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