Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06015230
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-29
First Post:
2023-06-01
Brief Title:
Clinical Study to Investigate the Safety Tolerability and Pharmacokinetics of GR1603 in SLE
Sponsor:
Genrix Shanghai Biopharmaceutical Co Ltd
Organization:
Genrix Shanghai Biopharmaceutical Co Ltd
Study Overview
Official Title:
A Phase ⅠbⅡ Randomized Double-blind Placebo-controlled Study to Investigate the Tolerability SafetyPharmacokinetics and Efficacy of an Intravenous Treatment Regimen of GR1603 in Subjects with Systemic Lupus Erythematosus
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
A Study to Investigate the Tolerability SafetyPharmacokinetics and efficacy of GR1603 in subjects with Systemic Lupus Erythematosus GR1603 injection is a monoclonal antibody targeting IFNAR1 which can block IFNAR binding to type I interferons such as IFNα and be used to treat systemic lupus erythematosus
Detailed Description:
This is a Phase IbⅡdouble blind multiple-dose study to evaluate the pharmacokinetics PK safetytolerability and efficacy of intravenously administered GR1603 in participants with active SLE despite receiving standard of care
Phase Ib is a multi-dose escalation phase in which 16 subjects are scheduled to enroll
A total of 120 subjects were randomly assigned to GR1603 injection low dose group high dose group or placebo group in phase Ⅱ
Phase Ib is a multi-dose escalation phase in which 16 subjects are scheduled to enroll
A total of 120 subjects were randomly assigned to GR1603 injection low dose group high dose group or placebo group in phase Ⅱ
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