An exploratory clinical trial on the efficacy and safety of recombinant human follicle stimulating hormone+recombinant luteinizing hormone (r-hFSH+r-hLH) in young patients with diminished ovarian reserve (DOR) (POSEIDON Group 3).

Start Date27 Jul 2023

Sponsor / Collaborator-

CTR20222626 / RecruitingPhase 1

一项随机、开放、两周期、两交叉的重组人促卵泡激素注射液LM001与果纳芬在健康女性受试者中的安全性和药代动力学比对研究

[Translation] A randomized, open-label, two-cycle, two-crossover study comparing the safety and pharmacokinetics of recombinant human follicle-stimulating hormone injection LM001 and GONAL-F in healthy female subjects

主要研究目的以康宁杰瑞（吉林）生物科技有限公司提供的重组人促卵泡激素注射液（代号：LM001）为受试制剂，按有关生物等效性试验的规定，以默克雪兰诺生产的重组人促卵泡激素注射液果纳芬为参比制剂，进行人体药代动力学比对研究。次要研究目的观察受试制剂LM001和参比制剂果纳芬®在健康受试者中的安全性。

[Translation]

Main research purpose The recombinant human follicle stimulating hormone injection (code: LM001) provided by Alphamab Oncology (Jilin) Biotechnology Co., Ltd. was used as the test preparation. According to the relevant provisions of the bioequivalence test, the recombinant human follicle stimulating hormone injection Gonal-f produced by Merck Serono was used as the reference preparation for a human pharmacokinetic comparison study. Secondary research purpose To observe the safety of the test preparation LM001 and the reference preparation Gonal-f® in healthy subjects.

Start Date20 Oct 2022

Sponsor / Collaborator

Alphamab Jilin Co., Ltd.

CTR20181723 / CompletedPhase 3

评价重组人促卵泡激素注射液（LM001）在体外受精-胚胎移植中行控制性超促排卵的有效性和安全性的Ⅲ期临床试验

[Translation] Phase III clinical trial to evaluate the efficacy and safety of recombinant human follicle-stimulating hormone injection (LM001) in controlled ovarian hyperstimulation during in vitro fertilization-embryo transfer

试验主要目的为评价重组人促卵泡激素注射液（LM001）在体外受精-胚胎移植中行控制性超促排卵的女性受试者中的有效性。次要目的为评价重组人促卵泡激素注射液（LM001）在体外受精-胚胎移植中行控制性超促排卵的女性受试者中的安全性和耐受性以及免疫原性。

[Translation]

The primary purpose of the trial is to evaluate the effectiveness of recombinant human follicle-stimulating hormone injection (LM001) in female subjects undergoing controlled super ovulation during in vitro fertilization-embryo transfer. The secondary purpose is to evaluate the safety, tolerability and immunogenicity of recombinant human follicle-stimulating hormone injection (LM001) in female subjects undergoing controlled super ovulation during in vitro fertilization-embryo transfer.

Start Date07 Jun 2019

Sponsor / Collaborator

Alphamab Jilin Co., Ltd.

100 Clinical Results associated with Follitropin alfa biosimilar(Suzhou Alphamab Co. Ltd.)

100 Translational Medicine associated with Follitropin alfa biosimilar(Suzhou Alphamab Co. Ltd.)

100 Patents (Medical) associated with Follitropin alfa biosimilar(Suzhou Alphamab Co. Ltd.)

100 Deals associated with Follitropin alfa biosimilar(Suzhou Alphamab Co. Ltd.)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	G03GA06	DB00066

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Infertility, Female	Phase 2	CN	Alphamab Jilin Co., Ltd.	23 Dec 2021

Clinical Result

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Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00989781 (CTgov)	Not Applicable	Polycystic Ovary Syndrome	41	recombinant human chorionic gonadotropin+Adrenocorticotropin+Dexamethasone+Recombinant human follicle stimulating hormone (Normal Women)	xkmfnlrkkw(fhkekyaldn) = zteqnhlppd fkwnaiqbbg (gybulxtpxh, pzncxqkzrz - frtkxjcdjp) View more	-	17 Oct 2017
				recombinant human chorionic gonadotropin+Adrenocorticotropin+Dexamethasone+Recombinant human follicle stimulating hormone (PCOS Women)	hzbsvbinjc(hssvucasjx) = wcmlvanqdx mkcqtnwvki (navvkzabxn, pxcvrrhppc - aoiafxzfcu) View more
NCT01185704 (ATTAC-PCO, CTgov)	Phase 3	Polycystic Ovary Syndrome	136	Cetrorelix acetate+Recombinant Human Choriogonadotropin (r-hCG)+Recombinant human follicle stimulating hormone (r-hFSH) (Day 1 Protocol)	bvjlemltes(ztegcstkdd) = tfssyxyjna gjrqebzuef (zxqlriotyu, htomjmqkwe - mbjxirjcma) View more	-	03 Jul 2013
				Cetrorelix acetate+Recombinant Human Choriogonadotropin (r-hCG)+Recombinant human follicle stimulating hormone (r-hFSH) (Day 7 Protocol)	bvjlemltes(ztegcstkdd) = rsbfxrdmne gjrqebzuef (zxqlriotyu, dygrqxoqkj - wzqltxpgha) View more

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