Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2026-01-01 @ 10:06 PM
Study NCT ID:
NCT03535103
Status:
UNKNOWN
Last Update Posted:
2018-05-29
First Post:
2018-05-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Safety and Pharmacokinetics of LM001 and Gonal-F® in Healthy Women
Sponsor:
Alphamab Jilin Co., Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Open-label, Two-Period, Two-Crossover Study to Compare the Safety and Pharmacokinetics of Recombinant Human Follicle Stimulating Hormone Injection (LM001) and Gonal-F® in Healthy Female Volunteers
Status:
UNKNOWN
Status Verified Date:
2018-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Brief Summary: LM001 is a recombinant human Follicle Stimulating Hormone (r-hFSH) Injection, which is proposed for Assisted Reproductive Technology (ART). This is a randomized, open-label, two-period, two-crossover study to evaluate the safety and pharmacokinetics of recombinant human follicle stimulating hormone injection (LM001), compared with Gonal-F®, both given subcutaneously.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: