[Translation] A multicenter, randomized, double-blind, positive parallel controlled study to evaluate the efficacy and safety of recombinant human chorionic gonadotropin for injection in assisted reproductive technology in Chinese women

主要目的：评价在获卵数方面的疗效相似性，并进行等效性对比。次要目的：评价在卵泡发育（成熟卵细胞数、受精卵数、卵裂细胞数）方面的疗效、在血清β-hCG/hCG阳性率、临床妊娠率、持续妊娠率、早期胚胎流失率方面的、在不良事件方面的安全性、在局部注射部位耐受性方面、在免疫原性方面的差异。

[Translation]

The primary objective was to evaluate the similarity of efficacy in terms of the number of oocytes retrieved and to conduct an equivalence comparison. The secondary objectives were to evaluate the efficacy in terms of follicular development (number of mature oocytes, number of fertilized oocytes, number of cleavage cells), serum β-hCG/hCG positive rate, clinical pregnancy rate, ongoing pregnancy rate, early embryo loss rate, safety in terms of adverse events, tolerance at the local injection site, and differences in immunogenicity.

Start Date23 Aug 2017

Sponsor / Collaborator

Livzon MABPharm Inc.

CTR20161028 / CompletedPhase 1

注射用重组人绒促性素与艾泽单次皮下注射给药在中国健康受试者体内的药代动力学比对研究

[Translation] Comparative study on the pharmacokinetic of recombinant human chorionic gonadotropin for injection and Aze in Chinese healthy subjects after single subcutaneous injection

主要目的：评价注射用重组人绒促性素与艾泽单次皮下注射给药在中国健康受试者体内药代动力学的相似性次要目的：评价注射用重组人绒促性素与艾泽单次皮下注射给药在中国健康受试者中安全性和免疫原性的相似性

[Translation]

Primary objective: To evaluate the similarity of pharmacokinetics between recombinant human chorionic gonadotropin for injection and Aze in Chinese healthy subjects after single subcutaneous injection Secondary objective: To evaluate the similarity of safety and immunogenicity between recombinant human chorionic gonadotropin for injection and Aze in Chinese healthy subjects after single subcutaneous injection

Start Date18 Dec 2016

Sponsor / Collaborator

Livzon MABPharm Inc.

ChiCTR-IIR-16010158 / RecruitingPhase 1IIT

A Single-Dose Study to Compare the pharmacokinetic parameters of LZM003 (T) and Ovidrel(R) using a subcutaneous injection administration in Healthy Chinese Subjects

Start Date15 Dec 2016

Sponsor / Collaborator

Chinese People's Liberation Army General Hospital

100 Clinical Results associated with Choriogonadotropin alfa biosimilar(Livzon Pharmaceutical Group, Inc.)

100 Translational Medicine associated with Choriogonadotropin alfa biosimilar(Livzon Pharmaceutical Group, Inc.)

100 Patents (Medical) associated with Choriogonadotropin alfa biosimilar(Livzon Pharmaceutical Group, Inc.)

Literatures (Medical) associated with Choriogonadotropin alfa biosimilar(Livzon Pharmaceutical Group, Inc.)

Drug Design, Development and TherapyQ3 · MEDICINE

<p>Comparative Pharmacokinetics, Bioequivalence and Safety Study of Two Recombinant Human Chorionic Gonadotropin Injections in Healthy Chinese Subjects</p>

Q3 · MEDICINE

ArticleOA

Author: Cai, Yun ; Yang, Tianli ; Wang, Jin ; Yu, Xueming ; Peng, Hongmei ; Mei, Hekun ; Wang, Rui

OBJECTIVETo evaluate the pharmacokinetics (PK), bioequivalence and safety profile of the recombinant human chorionic gonadotropin (r-hCG) injection formulation LZM003 (test drug) comparing with that of Ovidrel^® (reference drug) in healthy Chinese subjects.METHODSThis is a randomized, single-blind, single-dose, two-arm and two-period crossover Phase I study. Subjects were randomized evenly to a single dose of LZM003 or reference drug injected subcutaneously, with a 10-day or longer between-treatment washout period. PK parameters, anti-drug antibodies (ADAs), and adverse events (AEs) were assessed. The primary PK endpoints were area under the curve (AUC) of the concentration-time curve from zero to last quantifiable concentration (AUC_0-t), AUC from zero to infinity (AUC_0-∞), and peak concentration (C_max). Bioequivalence was determined by assessing whether the 90% confidence intervals (CIs) for the geometric mean ratio (GMR) of LZM003 to reference drug fell within predefined margins of 80% -125%.RESULTSForty-eight subjects (24 males and 24 females) were enrolled and one subject withdrew for personal reasons. Mean values of primary PK parameters were similar (p > 0.05) between LZM003 and the reference drug. The 90% CIs for primary PK endpoints' GMR of LZM003 to reference drug ranged between 0.9144 and 1.1845, which were within bioequivalence margins of 80-125%. Incidence of AEs was similar (p > 0.05) between the two groups. Neither LZM003 nor reference drug produced anti-drug antibody (ADA) in healthy subjects.CONCLUSIONLZM003 and reference drug were bioequivalent. The PK and safety assessments were similar (p > 0.05) between the two formulations in healthy Chinese subjects.TRIAL REGISTRATION NUMBERChiCTR-IIR-16010158 (http://www.chictr.org.cn).TRIAL REGISTRATION DATEDecember 15, 2016.

100 Deals associated with Choriogonadotropin alfa biosimilar(Livzon Pharmaceutical Group, Inc.)

External Link

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Infertility	CN	Livzon Pharmaceutical Group, Inc.	27 Apr 2021

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Infertility, Female	Preclinical	CN	Livzon MABPharm Inc.	23 Aug 2017

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