Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2026-02-25 @ 4:36 PM
Study NCT ID:
NCT04878705
Status:
UNKNOWN
Last Update Posted:
2021-07-19
First Post:
2021-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of TWP-201 in Healthy Female Subjects
Sponsor:
Shandong TheraWisdom Biopharma Co., Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Double-blind, Placebo-controlled, Single Dose, Escalation, Phase I Clinical Trial to Evaluate the Safety and Tolerability of TWP-201 in Healthy Female Subjects
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
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:
This study is a randomized, double-blind, placebo-controlled, single dose, escalation, phase I clinical trial to evaluate the safety and tolerability of recombinant human follicle stimulating hormone Fc fusion protein injection (TWP-201) in healthy female subjects. The objective of the trial is to evaluate the safety and tolerability of TWP-201 in healthy female subjects.
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?: