Ignite Creation Date:
2024-07-17 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468683
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-05-31
Brief Title:
F01 in the Treatment of Moderate-to-severe Refractory Systemic Lupus Erythematosus
Sponsor:
Shanghai Simnova Biotechnology CoLtd
Organization:
Shanghai Simnova Biotechnology CoLtd
Study Overview
Official Title:
A Phase I Clinical Study to Evaluate the Safety Pharmacokinetics and Preliminary Efficacy of F01 in Patients With Moderate-to-severe Refractory Systemic Lupus Erythematosus
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
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 is a phase I clinical study to evaluate the safety pharmacokinetic profile and preliminary efficacy of F01 in patients with moderate-to-severe refractory systemic lupus erythematosus
Detailed Description:
Approximately up to about 50 participants with moderate-to-severe refractory systemic lupus erythematosus are planned to enroll This study is divided into two stages dose escalation and dose extension
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?:
None