NCT06015230

Clinical Study to Investigate the Safety, Tolerability, and Pharmacokinetics of GR1603 in SLE

A Phase Ⅰb/Ⅱ, Randomized, Double-blind, Placebo-controlled Study to Investigate the Tolerability, Safety,Pharmacokinetics and Efficacy of an Intravenous Treatment Regimen of GR1603 in Subjects with Systemic Lupus Erythematosus

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 136 (estimated)
• Sponsor: Genrix (Shanghai) Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A Study to Investigate the Tolerability, Safety,Pharmacokinetics 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 Ib/Ⅱ,double blind, multiple-dose study to evaluate the pharmacokinetics (PK), safety，tolerability 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.

Conditions

• Lupus Erythematosus, Systemic

Interventions

Type	Name	Description
BIOLOGICAL	low dose GR1603 in phase Ⅰb	6 subjects in GR1603 low dose，2 subjects in placebo
BIOLOGICAL	high dose GR1603 in phaseⅠb	6 subjects in GR1603 high dose，2 subjects in placebo
BIOLOGICAL	low dose GR1603 in phase Ⅱ	low dose GR1603 monthly
BIOLOGICAL	high dose GR1603 in phase Ⅱ	high dose GR1603 monthly
BIOLOGICAL	Placebo in phase Ⅱ	Placebo

Timeline

• Start date: 2022-03-08
• Primary completion: 2028-06-10
• Completion: 2028-10-04
• First posted: 2023-08-29
• Last updated: 2024-09-25

Locations

1 site across 1 country: China